Recall Z-1846-2011 ยท GKA Abnormal Hemoglobin Quantitation
Bio-Rad Laboratories Inc
The VARIANT Sickle Cell Short Program ROM Card; Distributed by and Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CA The VARIANT Sickle Cell Short Program is designed as a qualitative screen for the presence of hemoglobins F, A, S, D, C and E in eluates of neonatal blood collected on filter paper by high-performance liquid chromatography. For in vitro diagnostic use.
| Date | Mar 29, 2011 (initiated Apr 22, 2010) |
| Status | Terminated |
| Reason | The presence of parameters for Version 40400-S on the labeled VARIANT Sickle Cell Short ROM Card instead of Version 80300-S. |
| Root cause | Other |
| Action | The firm, Bio-Rad, sent an "URGENT: MEDICAL DEVICE RECALL NOTIFICATION" letter dated April 22, 2010, to all customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine their inventory and quarantine the product; complete and return the MEDICAL DEVICE RECALL RETURN RESPONSE FORM via fax to: (510) 741-3954, Attn: Bio-Rad CSD Regulatory Affairs, and contact there regional Bio-Rad office for ROM Card replacement. If you have any questions, contact Bio-Rad CSD Regulatory Affairs Department at 510-724-7000. |
| Quantity | 10 units |
| Distribution | Worldwide distribution: USA including: MD, NJ and UT; and countries of: Italy and Singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K924813 | VARIANT SICKLE CELL SHORT PROGRAM Bio-Rad, Jan 14, 1993 |