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U.S. Department of Health and Human Services

Class 2 Device Recall Clinical Chemistry Total Bilirubin

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  Class 2 Device Recall Clinical Chemistry Total Bilirubin see related information
Date Initiated by Firm July 09, 2009
Date Posted April 16, 2012
Recall Status1 Terminated 3 on March 07, 2014
Recall Number Z-1425-2012
Recall Event ID 52748
510(K)Number K022339  
Product Classification Diazo colorimetry, bilirubin - Product Code CIG
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.
Code Information List Numbers: 6L45-20, 6L45-40 Lot Numbers: 64047HW00, 64048HW00, 65084HW00, 65088HW00, 69001HW00, 69002HW00, 72016HW00, 73038HW00, 73057HW00, 75036HW00, 76023HW00, 77014HW00, 69025HW00, 73015HW00, 76038HW00, 77015HW00.
Recalling Firm/
Manufacturer		 Abbott Laboratories Inc.
820 Mission St
South Pasadena CA 91030-3142
For Additional Information Contact
626-440-0705
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CIG and Original Applicant = ABBOTT LABORATORIES
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