Reported Nov 2, 2016 · Terminated
IMMULITE/ IMMULITE 1000 Systems CMM CMV IgM Assay, REF/Catalog Number LKCM1(D) - 100 tests (US), Siemens Material…
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?
4 of 4 products
| Model / number | Barcodes | Product as published |
|---|---|---|
LKCM1 | 00630414985718 | IMMULITE/ IMMULITE 1000 Systems CMM CMV IgM Assay, REF/ (D) - 100 tests (US), Siemens Material Number (SMN) 10370301 (US), Unique Device Identification Number (UDI) 00630414985718 (US) |
LKCM1 | and REF/ - 100 tests (OUS) | |
| — | 00630414963747 | 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. |
- Lot codes and dates
- UDI 00630414985718/Catalog #
- LKCM1(D)
Kit lot D0330UDI 00630414963747/Catalog #
- LKCM1
Kit lots 03300331
- Amount recalled
- US: 5 kits; Foreign: 372 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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