Z-1425-2012

Clinical Chemistry Total Bilirubin, 6L45-20 and 6L45-40. Used for the quantitative analysis of total...

Name: Z-1425-2012 Clinical Chemistry Total Bilirubin, 6L45-20 and 6L45-40. Used for the quantitative analysis of total...
Creator: Abbott Laboratories Inc.
Published: 2009-07-09
License: https://open.fda.gov/license/

Abbott Medical / initiated 2009-07-09 / Terminated / root cause: manufacturing process

FDA source

Abbott Laboratories Inc. began a recall of 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 on 2009-07-09. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1425-2012
Status: Terminated
Initiated: 2009-07-09
Posted: 2012-04-16
Terminated: 2014-03-07
Recalling firm: Abbott Medical
Product: 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.
Product code: CIG Diazo Colorimetry, Bilirubin
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: List Numbers: 6L45-20, 6L45-40 Lot Numbers: 64047HW00, 64048HW00, 65084HW00, 65088HW00, 69001HW00, 69002HW00, 72016HW00, 73038HW00, 73057HW00, 75036HW00, 76023HW00, 77014HW00, 69025HW00, 73015HW00, 76038HW00, 77015HW00.

Product code CIG

K022339Class IITotal BilirubinAbbott Laboratories / cleared 2002-09-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)