Recall Z-1537-2014 ยท JPD Hemoglobin A2 Quantitation
Bio-Rad Laboratories, Inc.
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.
| Date | May 2, 2014 (initiated Apr 8, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| 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 |
| Quantity | 457 kits |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K991127 | VARIANT II B-THALASSEMIA Bio-Rad, Jun 10, 1999 |