IMMULITE 2000/IMMULITE 2000XPi Systems CMM CMV IgM Assay — Class II medical device recall Z-0320-2017
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-0320-2017 |
|---|---|
| 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 | 00630414961163, 00630414985725 |
| Lot numbers | 255, 256, 257, 258, 259, 260, 261, 262, 263, 264, 266, 267, D255, D256, D257, D258, D259, D260, D261, D262, D263, D264, D266 |
| Model numbers | 200, 255, 256, 257, 258, 259, 260, 261, 262, 263, 264, 266, 267, L2KCM2 |
Product
IMMULITE 2000/IMMULITE 2000XPi Systems CMM CMV IgM Assay, REF/Catalog Number L2KCM2(D) - 200 tests (US), SMN 10370302 (US), UDI 00630414985725 (US); and REF/Catalog Number L2KCM2 - 200 tests (OUS), SMN 10371320 (OUS), UDI 00630414961163 (OUS); IVD --- Siemens Healthcare Diagnostics Products Ltd., Llanberis, Gwynedd, LL55 4EL UK For in vitro diagnostic use with IMMULITE 2000 analyzers for the qualitative detection of IgM antibodies to cytomegalovirus (CMV) in human serum or plasma (EDTA or heparinized), as an aid in the diagnosis of current and recent CMV infection in individuals with signs and symptoms of CMV infection or clinical suspicion of CMV infection. This assay is not FDA cleared or approved for use in testing (screening) blood or plasma donors, neonatal screening, or for use at point-of-care facilities.
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-0320-2017. 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.