Reported Jan 2, 2013 · Terminated
Access Immunoassay Systems Total T4 Calibrators, Part Number: 33805. The Access Total T4 Calibrators are intended to…
Beckman Coulter 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: Beckman Coulter Inc. · 250 S Kraemer Blvd · Brea, CA · 92821-6232
Is this the product you have?
- Access Immunoassay Systems Total T4 Calibrators
- Part Number33805. The Access Total T4 Calibrators are intended to calibrate the Access Total T4 assay for the quantitative determination of total thyroxine (T4) levels in human serum and plasma using the Access Immunoassay Systems. Total T4 assay results are used for diagnosis and confirmation of thyroid disorders such as hyper- and hypothyroidism
- Lot codes and dates
019818021654024072
- Amount recalled
- 6,634 units total (2,742 units in US)
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
- PR
Why it was recalled
A recall communication was initiated because Beckman has identified that Access Total T4 calibrator lots 019818, 021654, and 024072 do not meet their 12 month expiration date claim.
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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