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.
Recall
- Recall Number
- Z-1537-2014
- Event Number
- 68016
- Firm
- Bio-Rad Laboratories, Inc.
- FEI Number
- 2915274
- Product Code
- JPD
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- April 8, 2014
- Posted
- May 2, 2014
- Terminated
- May 30, 2014
- Address
- 4000 Alfred Nobel Dr, Hercules, CA, 94547-1803
Description
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.
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.
BIO-RAD Laboratories sent an URGENT: MEDICAL DEVICE LETTER in the US on April 8. 2014 and worldwide with letters sent to customers and subsidiaries on April 14, 2014. Subsidiaries were asked to translate the letter and distribute to all affected customers Custormer were asked to complete a CUSTOMER MEDICAL DEVICE CORRECTION RESPONSE FORM and fax it to the Bio-Rad CSD Regulatory Affairs Department at the number provided to confirm that you have received this important information
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.
457 kits