Clinical Chemistry Albumin BCG (AlbG) List Number 7D53-21 Clinical Chemistry Albumin BCG 510(k) K981758, Product Code CI
FDA device recall Z-1434-2012 · posted 2012-04-18 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories Inc.
- Reason for recall
- Observed particulate matter in some reagent cartridges.
- Action taken
- Abbott Laboratories sent a Product Recall notification letter dated March 10, 2010, to all affected customers. The notification letter contained an explanation, patient impact, neccassary actions, and contact information. Customers were instructed to determine if they currently have any of the affected product in their inventory. Discontinue use and destroy any remaining inventory of the affected product in accordance with their institution's policies and procedures. Completed the enclosed Customer Reply Form. If customers forwarded any of the affected product they should provide a copy of the notification letter to their customers. For any questions customers should call Customer Service at 1-877-422-2688. For questions regarding this recall call 626-440-0705.
- Root cause
- Material/Component Contamination
- Status
- Terminated
- Product code
- CIX
- Quantity affected
- 2718 (U.S. 652)
- Distribution
- US nationwide and internationally to Germany, Hong Kong, Australia, New Zealand, Trinidad/Tobago, and Jamaica. No dsitribution of Canada or Mexica.
- Date initiated
- 2010-03-10
- Date posted
- 2012-04-18
- Date terminated
- 2012-04-18
- Location
- South Pasadena, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ALBG (K981758) | Abbott Laboratories | 1998-06-12 |