Recall Z-0612-2011
Bio-Rad Laboratories Inc · initiated June 24, 2010
Product
Bio-Rad Laboratories Autoimmune EIA ANA Screening kit, 96 test, model 96AN, Distributed and Manufactured by Bio-Rad Laboratories, Inc.
Codes / lots: Manufactured on 06/07/2010, lot number 24501097
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..
FDA-determined 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.
Details
- Recall number
- Z-0612-2011
- Initiated
- June 24, 2010
- Posted by FDA
- December 13, 2010
- Terminated
- August 8, 2011
- Product code
- LKJ – Antinuclear Antibody, Antigen, Control
- Quantity
- 37 units
- Distribution
- Nationwide Distribution: including the states of California, Ohio, Massachusetts, and Missouri. Product delivered to 11 consignees only in the US.
- Recalling firm
- Bio-Rad Laboratories Inc, Hercules, CA