IMMULITE and IMMULITE 1000 Total Testosterone Assay- In vitro… — Class II medical device recall Z-0355-2023
Ongoing recall by Siemens Healthcare Diagnostics, Inc., reported 2022-12-14, distributed nationwide. Confirmed an average positive bias of 40% for testosterone concentrations of approximately 660 ng/dL (22.9 nmo
| Recall number | Z-0355-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., East Walpole, MA, United States |
| Recall initiated | 2022-10-25 |
| Classified | 2022-12-02 |
| Reported by FDA | 2022-12-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, BD, BG, BR, CA, CN, CO, CY, DE, EE, ES, GB, GR, IN, IT, LV, MX, RO, SG, UY, ZA |
| Quantity | 867 units |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 00630414964782 |
| Lot numbers | 515, 516 |
| Expiration dates | 2022-11-30, 2022-12-31 |
Product
IMMULITE and IMMULITE 1000 Total Testosterone Assay- In vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers for the quantitative measurement of total testosterone in serum and heparinized plasma.
Reason for recall
Confirmed an average positive bias of 40% for testosterone concentrations of approximately 660 ng/dL (22.9 nmol/L) and above with the IMMULITE/IMMULITE 1000 Total Testosterone Assay when compared to the IMMULITE 2000/IMMULITE 2000 XPi Total Testosterone Assay. Two (2) lots of Total Testosterone assays for the IMMULITE/IMMULITE 1000, kit lots #515 and #516 were actively distributed to customers when the issue was discovered by Siemens, and they are subject to the correction or removal in this recall (867 total quantity of reagents distributed for each lot). The violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. In both males and female, testosterone results are not used in isolation but are interpreted in conjunction with clinical history and symptomology as well as with other laboratory testing (e.g. gonadotropins and other sex steroids). A delay in the diagnosis may be experienced and medical intervention, such as repeat testing may be required.
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-0355-2023. 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.