Reported Jan 18, 2023 · Ongoing
IMMULITE 2000 Thyroglobulin (OUS). For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers for the…
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?
- IMMULITE 2000 Thyroglobulin (OUS). For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers for the quantitative measurement of thyroglobulin in serum or heparinized plasma, as an aid in monitoring patients who have undergone thyroidectomy. Catalog # Catalog #
- L2KTY2 Siemens Material Number (SMN)10381648
- Lot codes and dates
- UDI00630414962252
- Kit Lots
431432433434435and 436
- Amount recalled
- 7,543 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
- GA
Why it was recalled
Potential for Functional Sensitivity to not meet Instructions For Use (IFU) claims with the kit lots; control level one may result outside of published ranges; when control results are in range, users may observe increased imprecision with low level patient samples
This product could cause temporary or reversible health problems — stop using it.
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