Reported May 14, 2014 · Terminated
Variant II beta-thalassemia Short Program Model Numbers 270-2103 (250 tests) and 270-2154 (500 tests), Bio-Rad…
Bio-Rad Laboratories, 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: Bio-Rad Laboratories, Inc. · 4000 Alfred Nobel Dr · Hercules, CA · 94547-1803
Is this the product you have?
- Variant II beta-thalassemia Short Program Model Numbers 270-2103 (250 tests) and 270-2154 (500 tests), Bio-Rad Laboratories, Inc. in vitro diagnostic. The Variant II Hemoglobin testing system uses the principals of high performance liquid chromatography (HPLC) for the separation and determination of normal and abnormal hemoglobin.
- Lot codes and dates
- Catalog number270-2103 (250 tests
- Reorder pack lot number64005302
- Expiration4/2015
- Catalog number270-2154 (500
- tests) Reorder pack lot number64005207
- Expiration
6/201564004750
- Expiration11/2015
- Amount recalled
- 457 kits
Where it was sold
Why it was recalled
There is an issue with the buffers which impacts the quantification of the Hemoglobin F peak. Calibration and Quality control are likely to fail if the affected lots are used.
This product could cause temporary or reversible health problems — stop using it.
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