The VARIANT Sickle Cell Short Program ROM Card; Distributed by and Manufactured by: Bio-Rad Laboratories, Inc. Hercules,
FDA device recall Z-1846-2011 · posted 2011-03-29 · Terminated
Recall details
- Recalling firm
- Bio-Rad Laboratories Inc
- Reason for recall
- The presence of parameters for Version 40400-S on the labeled VARIANT Sickle Cell Short ROM Card instead of Version 80300-S.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- GKA
- Quantity affected
- 10 units
- Distribution
- Worldwide distribution: USA including: MD, NJ and UT; and countries of: Italy and Singapore.
- Date initiated
- 2010-04-22
- Date posted
- 2011-03-29
- Date terminated
- 2011-04-07
- Location
- Hercules, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VARIANT SICKLE CELL SHORT PROGRAM (K924813) | Bio-Rad | 1993-01-14 |