IMMULITE 2000 Systems HCG [200 Tests — Class II medical device recall Z-1015-2022
Ongoing recall by Siemens Healthcare Diagnostics, Inc., reported 2022-05-04, distributed nationwide. Potential for falsely elevated hCG results due to sample carryover in serum and urine patient samples, as well
| Recall number | Z-1015-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Tarrytown, NY, United States |
| Recall initiated | 2022-02-22 |
| Classified | 2022-04-28 |
| Reported by FDA | 2022-05-04 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 00630414961132, 00630414961149 |
| Lot numbers | 463, 464, 466, 467, 469, 470, 471, 472 |
Product
IMMULITE 2000 Systems HCG [200 Tests, material number 10381206, catalog number L2KCG] and [600 Tests, material number 10381194, catalog number L2KCG6]
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1015-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.