FDA-Device2014-05-14Class II
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.
Bio-Rad Laboratories, Inc.
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.
Sold states
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.
Affected count
457 kits
Manufactured in
4000 Alfred Nobel Dr, N/A, Hercules, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1537-2014Don't want to check this manually?
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