Autoimmune EIA ANA Screening Test Kit, 96 Tests, Model/Catalog Number: 96AN manufactured by Bio-Rad, Hercules, CA
FDA device recall Z-0539-2011 · posted 2010-12-06 · Terminated
Recall details
- Recalling firm
- Bio-Rad Laboratories Inc
- Reason for recall
- The ANA Screening kit generates a high percentage of false positive results, associated with a low check control reading.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LKJ
- 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.
- Date initiated
- 2010-03-01
- Date posted
- 2010-12-06
- Date terminated
- 2011-01-05
- Location
- Hercules, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ENZYME IMMUNOASSAY ANA SCREENING TEST KIT (K954723) | Helix Diagnostics, Inc. | 1995-12-15 |