Clinical Chemistry Total Bilirubin, 6L45-20 and 6L45-40. Used for the quantitative analysis of total bilirubin in human
FDA device recall Z-1425-2012 · posted 2012-04-16 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Material/Component Contamination
- Status
- Terminated
- Product code
- CIG
- Quantity affected
- 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.
- Date initiated
- 2009-07-09
- Date posted
- 2012-04-16
- Date terminated
- 2014-03-07
- Location
- South Pasadena, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TOTAL BILIRUBIN (K022339) | Abbott Laboratories | 2002-09-13 |