Recall Z-1434-2012 ยท CIX Bromcresol Green Dye-Binding, Albumin
Abbott Laboratories Inc.
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
| Date | Apr 18, 2012 (initiated Mar 10, 2010) |
| Status | Terminated |
| Reason | Observed particulate matter in some reagent cartridges. |
| Root cause | Material/Component Contamination |
| Action | 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 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981758 | ALBG Abbott Laboratories, Jun 12, 1998 |