Recall Z-1425-2012 ยท CIG Diazo Colorimetry, Bilirubin
Abbott Laboratories Inc.
Clinical Chemistry Total Bilirubin, 6L45-20 and 6L45-40. Used for the quantitative analysis of total bilirubin in human serum or plasma of adults and neonates.
| Date | Apr 16, 2012 (initiated Jul 9, 2009) |
| Status | Terminated |
| Reason | Abbott Laboratories has issued a recall on the Clinical Chemistry Total Bilirubin due to an under-recovery on one clinical neonatal specimen resulting in a value less than the assay linear limit. |
| Root cause | Material/Component Contamination |
| Action | Abbott Laboratories plans to release a Product Correction letter to customers instructing customers to follow the steps provided in order to revise their Total Bilirubin assay parameters. The letter explained the reason for the recall, along with the patient impact. Customers were to keep the letter as part of their laboratory records and also forward a copy to any other laboratories that they may have forwarded Total Bilirubin kits. U.S. Customers should contact Customer Service at 1-877-4ABBOTT, if they have questions. |
| Quantity | 11,282 |
| Distribution | Worldwide Distribution -- USA, Guatemala, Chile, Brazil, Canada, Germany, Hong Kong, Thailand, Puerto Rico, Australia, New Zealand, Trinidad & Tobago, Bermuda, Curacao, Cayman Island, and Jamaica. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022339 | TOTAL BILIRUBIN Abbott Laboratories, Sep 13, 2002 |