FDAFDA · Food and drugs·Recall number Z-1537-2014
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.
Published May 14, 2014 · Recall initiated: April 8, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Bio-Rad Laboratories, Inc.
- Distributor
- Worldwide Distrubution ; USA INCLUDING CA, NY, GA, NC, AL, NJ, CT, WA, NY, LA, Il, MA and Internationally to China, Australia, Canada, France, Great Britain, Hong Kong, Thailand, Singapore,and Brazil.
- Lot
- Catalog number: 270-2103 (250 tests; Reorder pack lot number: 64005302, Expiration: 4/2015; Catalog number: 270-2154 (500 tests) Reorder pack lot number: 64005207, Expiration: 6/2015; 64004750, Expiration: 11/2015
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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