Recall Z-0608-2011
Bio-Rad Laboratories Inc · initiated February 26, 2010
Product
Quest EIA ANA Screen Bulk Kit, model number 96AN-BPU-QUEST. Manufactured by Bio-Rad Laboratories, Inc., Hercules, CA. For labeling and distribution by Quest International Inc. Medical device is used as a qualitative enzyme immunoassay (EIA) intended to screen for the presence of antinuclear antibodies (ANAs) in human serum as an aid in the diagnosis of certain rheumatic diseases. This assay collectively detects, in one well, total ANAs against double stranded DNA (dsDNA, nDNA), histones, SS-A/Ro, SS-B/LA, Sm, Sm/RNP, Scl-70, Jo-1 and centromeric antigens along with sera positive for Immunofluorescent (IFA) HEp-2.
Codes / lots: 96AN-Bulk Pack Unlabeled Components (Catalog No. 96 AN-BPU-QUEST) for ANA Screening Test; Lot No. 24591991, 24592395, 24500249, 24500250; Expiration date: 6/2010 (Lot 24952395); 12/2010
Reason for recall
The value for the ANA Cutoff and ANA Positive Controls will decrease overtime resulting in an unusually elevated positivity rate for patient samples tested.
FDA-determined cause: Other
Action taken
Bio-Rad Laboratories, Inc. sent an URGENT MEDICAL DEVICE RECALL NOTIFICATION letter dated February 24, 2010, to their customer. The letter identified the product, the problem, and the action to be taken. The customer was instructed to: Examine inventory and quarantine affected product. Identify all customers that have received the affected product and immediately notify them. Instruct them to discontinue use of the affected product. Complete and return the enclosed MEDICAL DEVICE RECALL RESPONSE FORM. For questions regarding this recall call (510) 724-7000.
Details
- Recall number
- Z-0608-2011
- Initiated
- February 26, 2010
- Posted by FDA
- December 13, 2010
- Terminated
- January 5, 2011
- Product code
- LKJ – Antinuclear Antibody, Antigen, Control
- Quantity
- 453 kits
- Distribution
- Nationwide Distribution including FL
- Recalling firm
- Bio-Rad Laboratories Inc, Hercules, CA