CLASS II Device recall · Reported 14 Mar 2018 · FDA Enforcement Report
cobas 6000 Modular Series system recalled by Roche Diagnostics
Roche Diagnostics is recalling cobas 6000 Modular Series system, distributed nationwide in the US. The recall was initiated on 18 Jul 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0909-2018
- FDA event ID
- 79130
- Recalling firm
- Roche Diagnostics, Indianapolis, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Jul 2017
- FDA classified
- 6 Mar 2018
- Reported
- 14 Mar 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 18 Jul 2017 | Recall initiated by company | |
| 6 Mar 2018 | Classified by FDA | +231 days |
| 14 Mar 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A warning is being added to the cobas¿ 6000 MODULAR Series System - c501 and the cobas¿ 8000 MODULAR Analyzer Series - c502 Operator Manuals to prevent operator injury during maintenance.
Product as listed by the FDA
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
Where it was distributed
Distributed in all 50 states: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MN, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, the District of Columbia, and Puerto Rico.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusetts
Questions about this recall
Is cobas 6000 Modular Series system recalled?
Yes. Roche Diagnostics recalled cobas 6000 Modular Series system on 18 Jul 2017. The recall is Class II and its status is Terminated. Recall number Z-0909-2018.
Why was it recalled?
A warning is being added to the cobas¿ 6000 MODULAR Series System - c501 and the cobas¿ 8000 MODULAR Analyzer Series - c502 Operator Manuals to prevent operator injury during maintenance.
Which lots are affected?
Serial numbers: 0948-27 0933-27 1214-11 1297-08 0947-23 0932-23 1113-22 16U0-02 16Z4-02 1246-12 1255-08 14F9-15 14F9-16 14M9-15 14M9-16 0963-17 0949-12 0967-13 0953-28 1741-10 14A3-14 14D5-01 14D5-17 14K0-17 1163-13 1163-14 1146-13 1146-14 1166-18 1149-18 1146-15 1148-16 1113-25 1113-26 1157-01 1157-02 1113-13 1113-14 16Z6-02 0809-22 0888-22 0762-15 0770-07 0756-15 0770-14 0756-22 0825-28 0806-28 1175-11 1161-11 0809-29 0888-29 15K6-10 15U2-10 0626-07 0748-13 0749-10 0629-12 0747-01 14J2-18 1243-13 1247-09 14D7-16 14D7-18 14K3-16 14K3-18 14C0-06 14G5-18 14F9-18 14G3-19 14M9-18 14P2-19 14E2-01 14F0-12 14K9-01 14M1-12 0956-15 0941-30 1151-17 1151-18 1123-17 1123-18 0956-06 1147-03 1147-15 1147-16 1112-02 1113-21 0955-29 0941-14 14D8-04 14D8-05 14K5-04 14K5-05 14E4-09 14D8-01 14K5-01 1184-04 1184-05 1174-06 1174-07 0955-21 0955-27 0940-27 0941-12 0813-21 0813-29 0893-22 0893-30 0793-06 0793-07 0776-18 0831-09 0818-29 0793-10 0776-21 0793-09 0776-20 0753-13 0766-11 15G8-04 15P7-04 0772-18 0773-05 0758-15 0758-22 0965-17 0950-25 0817-15 0822-19 0803-19 0896-30 0832-05 0794-11 0777-21 0953-03 0937-24 1214-12 1297-09 15H9-20 15R9-20 0802-13 0881-13 1252-06 1270-01 14D5-09 14K0-09 14B3-13 14F5-14 0783-06 0768-04 1296-09 1296-10 1283-04 1283-05 14C3-10 15J9-13 15S8-08 1246-20 1255-16 0840-24 0825-16 0822-26 0803-26 0822-27 0803-27 16V2-04 16V2-05 1602-04 1602-05 16X0-04 1616-04 16S9-18 16Z3-18 15G8-10 15P7-10 0844-26 0829-26 0953-05 0937-26 0953-29 0938-30 1296-15 1283-10 0840-26 0828-19 0830-01 0813-29 0817-21 15L8-15 15V5-15 0768-05 0835-23 0953-08 0937-29 0958-12 0840-21 0825-13 1250-06 1265-01 15L6-15 14J3-12 0967-07 0953-22 13A1-06 13D1-06 15H9-18 15R9-18 0640-02 0640-13 1172-13 1172-14 1157-13 1157-14 0828-04 0813-14 0828-11 0813-21 0828-02 0813-12 15H9-05 15K0-10 15R9-05 15S9-05 16X4-01 16X4-03 1620-01 1620-03 1208-06 1291-03 14G3-18 14P2-18 14D4-02 14F9-09 14M9-09 1252-03 1269-08 1248-13 1260-09 16R9-01 16R9-02 16Y6-01 16Y6-02 0959-09 0945-14 14B0-04 14F0-16 1183-13 1173-11 1183-12 1173-10 14F9-13 14M9-13 14F9-14 14M9-14 14F8-20 14G0-03 15L8-07 15L8-09 15V5-07 15V5-09 14G2-03 14J3-11 16U0-05 16Z4-05 14A8-02 14B3-10 14F5-11 14B2-11 14D7-17 14K3-17 1356-12 1379-04 16S2-07 1249-19 1249-20 1263-11 1263-12 1236-01 1358-10 1380-06 1233-14 1252-19 1371-04 1233-13 1252-18 1371-03 1175-16 1161-16 1151-19 1123-19 1127-11 1182-11 1182-12 1172-09 1172-10 0808-26 0887-24 15P2-09 15P2-10 15W9-09 15W9-10 1145-20 1146-14 1113-27 1113-29 0817-09 0896-24 0812-30 0892-05 0967-08 0953-23 1250-07 1265-02 16W1-08 16W1-09 1610-08 1610-09 0822-22 0822-28 0803-22 0803-28 0946-12 0946-14 0946-15 0840-25 0840-27 0840-30 0825-17 0825-19 0825-22 1361-04 1384-10 16V7-17 1606-17 1619-06 1175-19 1175-20 1161-19 1161-20 0639-13 0640-04 0809-28 0888-28 0820-19 0813-25 0893-26 1169-16 1175-13 1161-13 1169-15 1157-18 14A9-09 14E8-11 0804-30 0883-15 0948-26 0933-26 15H9-10 15R9-10 14B1-08 14F3-02 16V9-04 1608-04 14B5-13 14B5-14 14F8-13 14F8-14 1174-17 1174-18 1160-17 1160-18 1241-03 1251-17 1251-20 1269-02 1269-05 0625-16 0629-01 0636-10 0637-21 0793-19 0776-30 1253-05 1371-10 16U5-03 16Z6-03 16V9-02 1608-02 0837-05 0822-30 0939-09 0821-28 0802-09 0776-15 0762-14 0953-19 0938-20 1182-08 1184-08 1172-06 1174-10 15G8-05 15P7-05 1184-06 1174-08 16W1-06 1610-06 16Z1-06 16Z2-01 1632-06 1633-01 0773-04 0773-10 0758-21 0758-27 0817-22 1295-03 1220-03 1255-12 14C0-05 14C1-06 14G5-17 14G9-02 14F3-05 14F3-06 14M4-05 14M4-06 0612-05 0612-05 0640-10 0640-21 16P7-10 16V2-07 16V8-12 1602-07 1607-12 16V8-16 1607-16 1242-06 1243-11 0831-01 0831-05 0840-28 0840-29 0825-20 0825-21 0828-05 0828-06 0813-15 0813-16 1188-11 1188-12 1177-10 1177-11 0948-25 0933-25 0752-13 0748-04 0836-09 0821-29 0952-30 0937-21 0953-16 0938-17 0953-11 0938-12 0953-26 0938-27 0947-29 0932-29 0805-21 0805-22 0884-06 0884-07 0836-03 0821-23 0836-04 0821-24 0640-03 0758-04 0640-14 0749-14 0640-16 0794-20 0640-26 0777-30 0816-26 0808-21 0887-19 0808-22 0887-20 16S0-08 16X3-20 1619-20 16X3-19 1619-19 0757-19 0749-07 0776-19 0762-18 16S1-03 16Z1-07 1632-07 0784-14 769-24 16R7-20 16V7-12 1606-12 16X0-01 1616-01 0821-25 0821-26 0802-06 0802-07 0955-20 0955-28 0940-26 0941-13 16V7-05 1606-05 16V7-20 1606-20 16W1-02 1610-02 0766-19 0899-13 0753-21 0880-13 1741-04 1151-05 1152-19 1122-14 1127-14 16U6-05 16Z7-05 1608-01 0776-17 0793-11 0762-16 0776-22 16X4-04 16X4-05 1620-04 1620-05 1017-11 1027-02 1027-03 1013-16 1083-17 1087-09 0965-16 0950-24 1220-18 1204-15 16Z1-14 16Z1-19 1632-14 1632-19 16Z1-13 16Z1-18 1632-13 1632-18 16Z1-11 1632-11 1632-12 1392-01 14A5-16 14A5-18 14E0-03 14E0-05 0808-20 0887-18 0953-02 0937-23 0624-18 0625-03 0627-22 0628-18 14C0-07 14G5-19 0942-04 1220-15 1220-16 1204-12 1204-13 0805-28 0884-13 0964-08 0942-05 0804-28 0883-13 0804-29 0883-14 1214-08 1297-05 0777-02 0762-21 0639-11 0640-02 1160-09 1117-04 1155-09 1132-08 1173-16 1173-17 1158-12 1158-13 0958-05 0944-03 0958-06 0944-04 0981-10 1014-02 1014-03 1083-23 1083-24 14A9-10 14E8-12 1356-09 1379-01 0627-20 0624-16 1221-16 1207-14 15H9-17 15R9-17 16R2-12 16Y0-12 1250-09 1265-04 0955-25 0941-01 14A5-12 14D9-19 14F9-12 14M9-12 1290-13 1221-13 1207-11 1246-17 1255-13 15P3-07 16U0-01 16Z4-01 0953-10 0938-11 16V7-14 16V7-15 1606-14 1606-15 16V7-16 1606-16 16S0-19 16X4-02 1620-02 0897-08 0804-21 0883-06 1395-03 13B7-11 1395-04 13B7-12 0809-21 0809-25 0888-21 0888-25 0814-10 0814-27 0805-26 0805-27 0884-11 0884-12 1182-09 1172-07 1290-09 1179-07 0967-15 0953-30 62024 14C1-07 14G9-03 1246-14 1246-15 1255-10 1255-11 0899-01 0880-01 1250-14 1265-09 14D4-19 0844-25 0829-25 0959-14 0959-17 0945-19 0945-22 1242-11 1243-16 1231-05 1242-12 1243-17 16V2-20 16V3-01 1602-20 1603-01 14B1-10 14B1-11 14F3-07 14F3-08 0636-18 0637-29 0770-19 14G0-05 15L8-02 15L8-08 15V5-02 15V5-08 0829-22 0844-22 0790-20 0783-04 0768-02 1250-15 1265-10 0639-06 0758-06 16V2-09 16V2-10 1602-09 1602-10 14A9-12 14E8-14 0772-11 0758-08 0772-16 0758-13 1394-09 1394-10 13B6-17 13B6-18 1232-14 0813-23 0893-24 1251-15 1268-10 0758-14 0766-06 0749-24 0753-08 14D7-19 14K3-19 14D7-20 14K3-20 0955-18 0956-01 0940-24 0941-16 0883-04 1246-18 1255-14 1146-13 1117-17 16W1-11 1610-11 0763-05 0772-12 0758-09 0826-28 0807-28 16X0-09 1616-09 0954-08 0939-16 14F9-08 14M9-08 14B5-08 14F8-08 14A5-15 14E0-02 1029-14 1099-11 0897-13 0783-13 0768-11 0802-19 0881-19 15K0-06 15S9-01 1251-12 1268-07 1377-11 1395-06 13B7-14 1171-18 1188-07 1214-17 1296-11 1177-06 1283-06 1297-14 16V7-06 16V7-07 1606-06 1606-07 0817-06 0817-07 0896-21 0896-22 0953-27 0938-28 14F0-06 16V9-03 1608-03 0770-16 0756-24 1242-08 1243-13 0618-16 0618-18 618-20 619-02 16R9-11 16Y6-11 16R9-12 16Y6-12 1253-03 1253-04 1371-08 1371-09 1741-05 1251-18 1251-19 1269-03 1269-04 1221-17 1207-15 0830-08 0817-28 14G3-01 14P2-01 16Z1-17 1291-19 1292-03 1219-01 1219-02 1176-15 1176-16 1162-11 1162-12 1188-09 1188-10 1177-08 1177-09 1214-13 1214-15 1297-10 1297-12 1175-17 1175-18 1161-17 1161-18 1358-14 1358-15 1359-07 1380-10 1380-11 1382-17 1026-04 1094-25 1146-09 1117-13 16R2-01 16Y0-01 1358-13 1380-09 1157-03 1157-05 1113-19 1113-20 0817-28 16V2-08 1602-08 16W1-05 1610-05 16V7-09 1606-09 1159-15 1136-20 1017-09 1087-07 0826-03 0945-21 0945-22 0930-21 0930-22 1152-17 1152-18 1127-12 1127-13 1208-08 1291-05 1252-12 1270-07 15K6-09 15U2-09 1155-12 1155-13 1132-11 1132-12 1160-02 1149-11 15J9-17 15S8-12 1159-13 1136-18 0828-20 0813-30 0642-06 0641-26 14F3-07 14M4-07 14M4-08 14D5-18 14D5-19 14K0-18 14K0-19 0641-15 14B2-13 14D5-10 14D5-11 14K0-10 14K0-11 0899-03 0880-03 14B3-09 14F5-10 14B2-12 14D8-03 14K5-03 1358-09 1380-05 1298-17 1222-15 1150-05 1150-06 1121-16 1121-17 0955-24 0940-30 0955-26 0941-02 0774-17 0760-25 0805-24 0884-09 15M6-19 15W5-19 15M6-18 15W5-18 0637-12 0638-13 0623-12 0626-26 0626-01 0774-18 0760-26 1188-19 1296-08 1283-03 14A5-14 14E0-01 1361-03 1384-09 1706-11 1706-12 1741-11 1741-12 16V2-06 16V2-12 1602-06 1602-12 1361-05 1361-06 1384-11 1384-12 0623-16 0641-01 0641-01 1250-03 1263-15 1619-16 15L8-06 15V5-06 16V8-08 1607-08 15J9-20 15S8-15 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1297-06 1221-14 1207-12 1245-18 1252-14 14B3-02 14D5-20 14K0-20 16V7-10 1606-10 0955-17 0940-23 0817-29 0897-24 16R2-16 16Y0-16 0639-02 0639-23 0954-07 0939-15 16U5-07 16U5-08 16Z6-07 16Z6-08 1242-05 1243-10 14F9-10 14M9-10 1183-14 1173-12 16S9-10 16Z3-10 14B5-09 14F8-09 15H9-14 15J4-10 15R9-14 15S3-10 15J9-07 15J9-10 15S8-02 15S8-05 15J9-06 15J9-11 15S8-01 15S8-06 16R2-11 16Y0-11 0747-20 0746-01 0637-18 0638-19 0804-24 0883-09 1164-13 1182-07 1172-05 1215-14 1298-10 14F3-14 14M4-14 0783-17 0768-15 0768-03 0754-25 0631-01 0633-12 15H9-07 15R9-07 14E4-03 15K6-12 15U2-12 0776-12 0762-11 0783-20 14G3-05 14P2-05 15K6-13 15K6-14 15U2-13 15U2-14 15H9-13 15J4-15 15R9-13 15S3-15 1175-14 1175-15 1161-14 1161-15 15J4-18 15S3-18 1215-18 1298-14 1032-13 1032-14 1003-26 1003-27 0817-01 0896-16 15P2-01 15W9-01 16U5-16 16Z6-16 14E2-09 14F0-01 14K9-09 14M1-01 0630-02 0632-13 15J4-03 15S3-03 15G8-14 15P7-14 1245-13 1245-14 1245-15 1252-09 1252-10 1252-11 1741-08 0813-28 0817-10 0893-29 0896-25 0964-06 1017-03 1017-10 1087-01 1087-08 15K6-06 15U2-06 1250-01 1250-02 1263-13 1263-14 1019-16 1088-29 1143-08 1115-02 0981-01 0965-18 0950-26 16U0-12 16U0-13 16Z4-12 16Z4-13 16S9-13 16U0-10 16Z3-13 16Z4-10 16S0-07 16W1-01 1610-01 1204-06 1378-07 1380-12 13C2-07 13C2-08 0958-08 0944-06 1247-04 1247-05 1390-05 13B2-20 14D5-14 14K0-14 14E2-12 14E2-13 14K9-12 14K9-13 16R2-02 16Y0-02 16R8-08 16V8-20 1607-20 16R8-07 16V7-18 1606-18 1243-08 1243-09 0958-03 0944-01 1248-14 1260-10
Where was it sold?
Distributed in all 50 states: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MN, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, the District of Columbia, and Puerto Rico.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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