Reported Nov 2, 2016 · Terminated
IMMULITE 2000/IMMULITE 2000XPi Systems CMM CMV IgM Assay, REF/Catalog Number L2KCM2(D) - 200 tests (US), SMN 10370302…
Siemens Healthcare Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics, Inc. · 511 Benedict Ave · Tarrytown, NY · 10591-5005
Is this the product you have?
3 of 3 products
| Model / number | Barcodes | Product as published |
|---|---|---|
L2KCM2 | 00630414985725 | IMMULITE 2000/IMMULITE 2000XPi Systems CMM CMV IgM Assay, REF/ (D) - 200 tests (US), SMN 10370302 (US), UDI 00630414985725 (US) |
L2KCM2 | 00630414961163 | and REF/ - 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. |
- Lot codes and dates
- UDI 00630414985725/Catalog #
- L2KCM2(D)
Kit lots D255D256D257D258D259D260D261D262D263D264D266UDI 00630414961163/Catalog #
- L2KCM2
Kit lots 255256257258259260261262263264266267
- Amount recalled
- US: 326 kits; Foreign: 9633 kits
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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