CLASS II ONGOING Device recall · Reported 4 May 2022 · FDA Enforcement Report
Immulite 2000 Systems HCG [200 Tests, material number recalled
Siemens Healthcare Diagnostics is recalling Immulite 2000 Systems HCG [200 Tests, material number 10381206, distributed nationwide in the US. The recall was initiated on 22 Feb 2022 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-1015-2022
- FDA event ID
- 89900
- Recalling firm
- Siemens Healthcare Diagnostics, Tarrytown, NY
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Feb 2022
- FDA classified
- 28 Apr 2022
- Reported
- 4 May 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 22 Feb 2022 | Recall initiated by company | |
| 28 Apr 2022 | Classified by FDA | +65 days |
| 4 May 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for falsely elevated hCG results due to sample carryover in serum and urine patient samples, as well as quality control samples and adjustors.
Product as listed by the FDA
IMMULITE 2000 Systems HCG [200 Tests, material number 10381206, catalog number L2KCG] and [600 Tests, material number 10381194, catalog number L2KCG6]
Where it was distributed
Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, HI, ID, IN, MN, NC, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TX, VA, WI, WY and OUS: 81 countries.
Nationwide ArizonaCaliforniaColoradoFloridaGeorgiaHawaiiIdahoIndianaMinnesotaNorth CarolinaNew HampshireNew JerseyNew MexicoNevadaNew YorkOhioOregonPennsylvaniaSouth CarolinaTexas
Questions about this recall
Is Immulite 2000 Systems HCG [200 Tests, material number 10381206 recalled?
Yes. Siemens Healthcare Diagnostics recalled Immulite 2000 Systems HCG [200 Tests, material number 10381206 on 22 Feb 2022. The recall is Class II and its status is Ongoing. Recall number Z-1015-2022.
Why was it recalled?
Potential for falsely elevated hCG results due to sample carryover in serum and urine patient samples, as well as quality control samples and adjustors.
Which lots are affected?
8 production lots: 463, 464, 466, 467, 469, 470, 471, 472, [UDI for 200 tests: (01)00630414961132(10)463(17)20220228, (01)00630414961132(10)464(17)20220331, (01)00630414961132(10)466(17)20220331, (01)00630414961132(10)467(17)20220531, (01)00630414961132(10)469(17)20220731, (01)00630414961132(10)470(17)20220930, (01)00630414961132(10)471(17)20221130, (01)00630414961132(10)472(17)20230228] [UDI for 600 tests: (01)00630414961149(10)463(17)20220228, 01)00630414961149(10)464(17)20220331, (01)00630414961149(10)466(17)20220331, (01)00630414961149(10)467(17)20220531, (01)00630414961149(10)469(17)20220731, (01)00630414961149(10)470(17)20220930, (01)00630414961149(10)471(17)20221130, (01)00630414961149(10)472(17)20230228]
Where was it sold?
Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, HI, ID, IN, MN, NC, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TX, VA, WI, WY and OUS: 81 countries.
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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