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U.S. Department of Health and Human Services

Class 3 Device Recall ARCHITECT B12 Reagents

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 Class 3 Device Recall ARCHITECT B12 Reagentssee related information
Date Initiated by FirmAugust 19, 2004
Date PostedSeptember 14, 2004
Recall Status1 Terminated 3 on July 29, 2005
Recall NumberZ-1452-04
Recall Event ID 29911
510(K)NumberK984108 
Product Classification Radioassay, Intrinsic Factor Blocking Antibody - Product Code LIG
ProductARCHITECT B12 Reagents, List 6C09-20 (4 x 100 tests) and List 6C09-25 (100 tests); Abbott Laboratories, Abbott Park, IL 60064 USA; Abbott, Max-Planck-Ring 2, 65205 Wiesbaden, Germany
Code Information List 6C09-20, lots 11002M300, 11003M300, 16051M200, 18288M300; List 6C09-25, lots 11002M301, 16051M201, 18288M301 
FEI Number 1415939
Recalling Firm/
Manufacturer		 Abbott Laboratories HPD/ADD/GPRD
100 Abbott Park Rd
Abbott Park IL 60064-3502
Manufacturer Reason
for Recall		Changes in the ARCHITECT B12 Reagent lots may adversely affect the shape of the calibration curve, over time. These changes may produce controls out of range low and similar decreases in patient sample values prior to current expiration of the reagents.
FDA Determined
Cause 2		Other
ActionAbbott affiliates in Canada, Germany, Singapore, Hong Kong, Australia, New Zealand and Japan were e-mailed copies of the recall letter on 8/19/04 for translation where needed and dissemination to their accounts receiving the suspect lots. The end users were advised of the potential for changes in the reagents over time that affect the shape of the calibration curve, producing controls out of range low and similar decreases in patient sample values. The accounts were instructed to manually update the expiration dates for the reagent lots according to the chart given in the recall letter for any of the affected lots remaining in inventory. The expiration date reported by the Architect instrument must also be manually updated.
Quantity in Commerce5754 kits
DistributionCanada, Germany, Singapore, Hong Kong, Australia, New Zealand and Japan.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LIG
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