Recall Z-1846-2011
Bio-Rad Laboratories Inc · initiated April 22, 2010
Product
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.
Codes / lots: Catalog number 270-0500, lot numbers 70000349, 70000353, both with expiration dates of 6/30/2011, which contains ROM Card Lot # LA82418 (Catalog # 270-0507). Rom Card is included in kit Lot number 70000349 and 70000353.
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.
FDA-determined cause: Other
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.
Details
- Recall number
- Z-1846-2011
- Initiated
- April 22, 2010
- Posted by FDA
- March 29, 2011
- Terminated
- April 7, 2011
- Product code
- GKA – Abnormal Hemoglobin Quantitation
- Quantity
- 10 units
- Distribution
- Worldwide distribution: USA including: MD, NJ and UT; and countries of: Italy and Singapore.
- Recalling firm
- Bio-Rad Laboratories Inc, Hercules, CA