CLASS II Device recall · Reported 1 Aug 2018 · FDA Enforcement Report
PR4100 Microplate Reader US recalled by Bio-Rad Laboratories
Bio-Rad Laboratories is recalling PR4100 Microplate Reader US, distributed nationwide in the US. The recall was initiated on 2 Apr 2018 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-2541-2018
- FDA event ID
- 80403
- Recalling firm
- Bio-Rad Laboratories, Redmond, WA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Apr 2018
- FDA classified
- 25 Jul 2018
- Reported
- 1 Aug 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 2 Apr 2018 | Recall initiated by company | |
| 25 Jul 2018 | Classified by FDA | +114 days |
| 1 Aug 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The connector of the power supply was capable of fitting other components provided with the system. However, the voltage output of the reader power supply is incompatible with the other component and, if incorrectly connected, could result in irreparable damage to the system.
Product as listed by the FDA
PR4100 Microplate Reader US, Catalog Number 45591587 Product Usage: The PR4100 Microplate Reader is a 96 well absorbance reader for the measurement of light absorbance (optical density-OD) of liquid media. The instrument is intended to be used primarily for the in vitro diagnostic analysis of samples from the human body to obtain information oh physiological and pathological states.
Where it was distributed
US Nationwide Distribution inn the states of : AL, AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OR, PA, SC, TN, TX, VA, VT, WA, WI, and Puerto Rico.
Nationwide AlabamaArkansasArizonaCaliforniaColoradoConnecticutFloridaGeorgiaHawaiiIllinoisIndianaKansasLouisianaMassachusettsMarylandMichiganMinnesotaMissouriMississippiNorth Carolina
Questions about this recall
Why was it recalled?
The connector of the power supply was capable of fitting other components provided with the system. However, the voltage output of the reader power supply is incompatible with the other component and, if incorrectly connected, could result in irreparable damage to the system.
Which lots are affected?
UDI: 00847865014151 Serial Numbers: 140600072, 160900991, 161001953, 1112001938, 1112001941 , 1112004075 , 1112004079 , 1112004083 , 1112004084 , 1112004086 , 1112004088 , 1112004093 , 1201003822 , 1201003826 , 1201003827 , 1207001007 , 1207001015 , 1207001017 , 1207001018 , 1208001583 , 1208001584 , 1208001586 , 1208001590 , 1208005236 , 1208005244 , 1208005245 , 1211000978 , 1211000983 , 1211006938 , 1301003205 , 1301003212 , 1303000299 , 1303000300 , 1303000302 , 1303000305 , 1303007688 , 1306003195 , 1307006044 , 1307006045 , 1307006054 , 1307006055 , 1308000967 , 1308000968 , 1308000969 , 1308000971 , 1308000973 , 1308003338 , 1308003341 , 1308003345 , 1308003346 , 1308006670 , 1311008542 , 1311008544 , 1311008546 , 1311008555 , 1311008557 , 1311008562 , 1311008564 , 1311008565 , 1401002580 , 1401002583 , 1401002587 , 1401007785 , 1401007786 , 1401007789 , 1401007792 , 1401007793 , 1404000065 , 1404000066 , 1404000067 , 1404000068 , 1404002677 , 1404002684 , 1404002685 , 1405005640 , 1405005641 , 1405005645 , 1405005648 , 1406000064 , 1406000065 , 1406000066 , 1406000067 , 1406000068 , 1406000070 , 1406000071 , 1406000074 , 1406006883 , 1406006886 , 1407004144 , 1407004145 , 1407004147 , 1407004149 , 1407004151 , 1407004152 , 1410010410 , 1410010415 , 1410010416 , 1411010876 , 1411010877 , 1411010880 , 1412001714 , 1412001716 , 1412001721 , 1501001523 , 1501001526 , 1501001526 , 1501005823 , 1501005824 , 1501005825 , 1501005828 , 1501005829 , 1501005832 , 1506008687 , 1506008690 , 1506008695 , 1510005389 , 1510005393 , 1510005394 , 1510005395 , 1510005397 , 1510005398 , 1510005399 , 1510005414 , 1601001552 , 1601001553 , 1601001559 , 1601001561 , 1601001562 , 1601001563 , 1603001786 , 1603005407 , 1605000088 , 1609000992 , 1609000993 , 1609000994 , 1609000995 , 1609000996 , 1609001301 , 1609001302 , 1609001303 , 1609001304 , 1609001305 , 1609001306 , 1609009231 , 1610001955 , 1701001785 , 1701001788 , 1701004204 , 1701004210 , 1710010533 , 1710010539 , 13060003204 , 16303005411 , s1411010876
Where was it sold?
US Nationwide Distribution inn the states of : AL, AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OR, PA, SC, TN, TX, VA, VT, WA, WI, 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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Bio-Rad Laboratories
All 27| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Platelia Toxo IgM recalled by Bio-Rad Laboratories | Bio-Rad Laboratories | Potency & Assay | Nationwide |
| Device | CLASS II | Bio-Rad, REF: 12005660, QXDx Bcr-abl %IS Kit recalled | Bio-Rad Laboratories | Other | Nationwide |
| Device | CLASS II | BioPlex 2200 REF 665-2050, Apls IgM Pack, Apls IgM Reagent Pack recalled | Bio-Rad Laboratories | Packaging Defects | Nationwide |
| Device | CLASS II | BioPlex 2200, Anti-CCP Reagent Pack recalled by Bio-Rad Laboratories | Bio-Rad Laboratories | Other | Nationwide |
| Device | CLASS II | BioPlex 2200, Anti-CCP Calibrator Set recalled by Bio-Rad Laboratories | Bio-Rad Laboratories | Other | Nationwide |
Other Test Kits & Diagnostics recalls
All 2,661| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | McKesson Consult hCG Urine Cassette recalled by Alere San Diego | Alere San Diego | Potency & Assay | Nationwide |
| Device | CLASS II | Systems/units containing affected recalled | Beckman Coulter Mishima K.K | Device Malfunction | Nationwide |
| Device | CLASS II | Fisher Scientific Sure-Vue Urine hCG recalled by Alere San Diego | Alere San Diego | Potency & Assay | Nationwide |
| Device | CLASS II | Vitek 2 Ast-N461 Test Kit, Gram Negative Susceptibility recalled | Biomerieux | Other | MO |
| Device | CLASS II | DASH Rapid PCR Instrument recalled by Nuclein | Nuclein | Device Malfunction | Nationwide |