Recall Z-1434-2012
Abbott Laboratories Inc. · initiated March 10, 2010
Product
Clinical Chemistry Albumin BCG (AlbG) List Number 7D53-21 Clinical Chemistry Albumin BCG 510(k) K981758, Product Code CIX The Albumin BCG assay is used for the quantitation of albumin in human serum or plasma
Codes / lots: Lot Numbers: 77056HW00; 80051HW00; 83030HW00 Exp dates: 04/15/2011, 07/15/2011, and 10/10/2011, respectively.
Reason for recall
Observed particulate matter in some reagent cartridges.
FDA-determined cause: Material/Component Contamination
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.
Details
- Recall number
- Z-1434-2012
- Initiated
- March 10, 2010
- Posted by FDA
- April 18, 2012
- Terminated
- April 18, 2012
- Product code
- CIX – Bromcresol Green Dye-Binding, Albumin
- Quantity
- 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.
- Recalling firm
- Abbott Laboratories Inc., South Pasadena, CA