Recall Z-0539-2011
Bio-Rad Laboratories Inc · initiated March 1, 2010
Product
Autoimmune EIA ANA Screening Test Kit, 96 Tests, Model/Catalog Number: 96AN manufactured by Bio-Rad, Hercules, CA
Codes / lots: Lot Numbers: 24591573, 24591983, 24592004, 24592036, 24592098, 24592377, 24592455, 24500033, 24500216
Reason for recall
The ANA Screening kit generates a high percentage of false positive results, associated with a low check control reading.
FDA-determined 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.
Details
- Recall number
- Z-0539-2011
- Initiated
- March 1, 2010
- Posted by FDA
- December 6, 2010
- Terminated
- January 5, 2011
- Product code
- LKJ – Antinuclear Antibody, Antigen, Control
- 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.
- Recalling firm
- Bio-Rad Laboratories Inc, Hercules, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0540-2011 | Autoimmune EIA ANA Screening Test Kit, 576 Tests, Model/Catalog Number: 576AN…The ANA Screening kit generates a high percentage of false positive results, associated with a low check… | 03/01/2010Terminated |