IMMULITE/ IMMULITE 1000 Systems CMM CMV IgM Assay — Class II medical device recall Z-0319-2017
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2016-11-02, distributed nationwide. Multiple customers reported seeing an increase in imprecision with some patients resulting in high % CVs with
| Recall number | Z-0319-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Tarrytown, NY, United States |
| Recall initiated | 2016-08-30 |
| Classified | 2016-10-27 |
| Reported by FDA | 2016-11-02 |
| Terminated | 2018-06-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AF, AR, AU, BD, BE, BG, BH, BO, BR, CH, CL, CN, CO, CR, CY, CZ, DE, DO, DZ, EC, EG, ES, FR, GB, GR, GT, HN, HU, IN, IQ, IT, JO, KR, LB, LT, LU, LV, MX, MY, NI, NL, NO, NP, PE, PK, PL, PT, PY, QA, RO, RS, SA, SG, SK, SV, TN, TR, UY, VN, ZA |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 00630414963747, 00630414985718 |
| Lot numbers | 0330, 0331, D0330 |
| Model numbers | 0330, 0331, 100, LKCM1 |
Product
IMMULITE/ IMMULITE 1000 Systems CMM CMV IgM Assay, REF/Catalog Number LKCM1(D) - 100 tests (US), Siemens Material Number (SMN) 10370301 (US), Unique Device Identification Number (UDI) 00630414985718 (US); and REF/Catalog Number LKCM1 - 100 tests (OUS); SMN 10381296 (OUS), UDI 00630414963747 (OUS); IVD --- Made in UK Siemens Healthcare Diagnostics Products Ltd., Glyn Rhonwy, Llanberis, Gwynedd, LL55 4EL UK For in vitro diagnostic use with the IMMULITE Systems Analyzers for the qualitative detection of IgM antibodies to Cytomegalovirus (CMV) in human serum or plasma (EDTA or heparinized), as an aid in the determination of an acute CMV infection.
Reason for recall
Multiple customers reported seeing an increase in imprecision with some patients resulting in high % CVs with the IMMULITE 2000/2000XPi CMV (IgM) assay starting with reagent lots 259 and above.
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-0319-2017. 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.