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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Abbott Laboratories Inc.
Lot Codes / Batch Numbers
List Numbers: 6L45-20, 6L45-40 Lot Numbers: 64047HW00, 64048HW00, 65084HW00, 65088HW00, 69001HW00, 69002HW00, 72016HW00, 73038HW00, 73057HW00, 75036HW00, 76023HW00, 77014HW00, 69025HW00, 73015HW00, 76038HW00, 77015HW00.
Products Sold
List Numbers: 6L45-20, 6L45-40 Lot Numbers: 64047HW00, 64048HW00, 65084HW00, 65088HW00, 69001HW00, 69002HW00, 72016HW00, 73038HW00, 73057HW00, 75036HW00, 76023HW00, 77014HW00, 69025HW00, 73015HW00, 76038HW00, 77015HW00.
Abbott Laboratories Inc. is recalling Clinical Chemistry Total Bilirubin, 6L45-20 and 6L45-40. Used for the quantitative analysis of tota due to Abbott Laboratories has issued a recall on the Clinical Chemistry Total Bilirubin due to an under-recovery on one clinical neonatal specimen resulting. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
PR
Page updated: Jan 10, 2026