Bio-Rad Laboratories Autoimmune EIA ANA Screening kit, 96 test, model 96AN, Distributed and Manufactured by Bio-Rad Laboratories, Inc.
- Company
- Bio-Rad Laboratories Inc
- Recall Initiated
- June 24, 2010
- Posted
- December 13, 2010
- Terminated
- August 8, 2011
- Recall Number
- Z-0612-2011
- Quantity
- 37 units
- Firm Location
- Hercules, CA
Reason for Recall
Product mislabeled-- the ANA cutoff Control and Prostiva controls were mislabeled. Use of the incorrect controls will cause run failure - patient results cannot be reported because controls will not pass..
Distribution
Nationwide Distribution: including the states of California, Ohio, Massachusetts, and Missouri. Product delivered to 11 consignees only in the US.
Lot / Code Info
Manufactured on 06/07/2010, lot number 24501097
Root Cause
Labeling mix-ups
Action Taken
Bio-Rad issued Medical Device Recall Notification letters dated June 24, 2010 to consignees, identifying the affected products and requested that all affected product be disposed of in accordance with local procedures. Response forms are to be completed and returned to the firm. Bio-Rad can be contacted for replacement product and about this recall at 510 741-6114.