Bio Rad brand Autoimmune EIA ANA Screening Kit, 96 Tests, Catalog No. 96AN-BPU-TRINITY. Manufactured by: Bio-Rad Laborat
FDA device recall Z-1479-2011 · posted 2011-03-02 · Terminated
Recall details
- Recalling firm
- Bio-Rad Laboratories Inc
- Reason for recall
- The firm received customer complaints of increased positivity rates associated with the ANA Screening kit due to a decline in stability.
- Action taken
- An Urgent: Medical Device Recall Notification, dated March 1, 2010, was provided to the firm's consignee, identifying the affected product and stating the reason for the recall. The letter also asked the customer to examine their inventory and quarantine the affected kits. If the product had been further distributed, those customers must be identified, notified, and asked to discontinue use of the affected product. Customers were to discard all affected product and complete and return the enclosed Medical Device Recall Response Form. The letter also stated that replacement kits would be available in mid-March.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LKJ
- Quantity affected
- 2,109 bulk packs
- Distribution
- Nationwide Distribution -- New York, US.
- Date initiated
- 2010-03-01
- Date posted
- 2011-03-02
- Date terminated
- 2011-03-11
- 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 |