Autoimmune EIA ANA Screening Test Kit, 96 Tests, Model/Catalog Number: 96AN manufactured by Bio-Rad, Hercules, CA
- Company
- Bio-Rad Laboratories Inc
- Recall Initiated
- March 1, 2010
- Posted
- December 6, 2010
- Terminated
- January 5, 2011
- Recall Number
- Z-0539-2011
- Firm Location
- Hercules, CA
Reason for Recall
The ANA Screening kit generates a high percentage of false positive results, associated with a low check control reading.
Distribution
Worldwide Distribution: Throughout the US, and to the countries of: Australia, Canada, France, Hong Kong, India, Italy, Japan, New Zealand, Panama, Singapore, South Korea and the UK.
Lot / Code Info
Lot Numbers: 24591573, 24591983, 24592004, 24592036, 24592098, 24592377, 24592455, 24500033, 24500216
Root Cause
Other
Action Taken
Bio-Rad issued an Urgent Medical Device Recall Notification letter dated March 1, 2010 to customers describing the issue and actions to be taken. Responses will be tracked via response forms. The letter instructed customers that affected products should be identified, quarantined, and discarded, or reworked with shorter expiration dates until newer lots are available. Bio-Rad can be contacted at 510-724-7000 concerning this recall.