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.
FDA Recall Z-1537-2014 · Posted 2014-05-02
Advertisement
Recalling FirmBio-Rad Laboratories, Inc.
Recall StatusTerminated
Product CodeJPD
Date Initiated2014-04-08
Date Terminated2014-05-30
Product Quantity457 kits
Reason for Recall
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.
Firm Action
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
Root Cause
Nonconforming Material/Component
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement