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U.S. Department of Health and Human Services

Class 2 Device Recall ARCHITECT Folate Reagent Kit

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 Class 2 Device Recall ARCHITECT Folate Reagent Kitsee related information
Date Initiated by FirmMarch 11, 2005
Date PostedApril 28, 2005
Recall Status1 Terminated 3 on January 18, 2006
Recall NumberZ-0783-05
Recall Event ID 31410
Product Classification Acid, Folic, Radioimmunoassay - Product Code CGN
ProductARCHITECT Folate Reagent Kit, list 6C12-20 ( 4 x 100 tests), 6C12-25 (1 x 100 tests) and 6C12-30 (4 x 500 tests), Abbott Laboratories, Abbott Park, IL 600064 U.S.A.
Code Information lot numbers 21082M200, 22024M100, 21082M201, 22024M101, 16603M200, and 22025M100
Recalling Firm/
Manufacturer		 Abbott Laboratories MPG
100 Abbott Park Rd
Abbott Park IL 60064-3502
For Additional Information ContactAbbott Customer Support
877-422-2688
Manufacturer Reason
for Recall		concentrations for normal samples generated with current reagent lots of the ARCHITECT Folate assay are lower than data generated for the package insert.
FDA Determined
Cause 2		Other
ActionAbbott international affilates were notified of the recall by e-mail on 03/11/2005, and requested to notifiy their customers. The letters inform the end users of the downward shift in control and/or patient results, and requested them to assess their normal and deficient ranges for their specific population, assess their quality control ranges and follow their laboratory procedures for reviewing patient results and notifying Health Care Providers that they serve. There was no U.S. distribution.
Quantity in Commerce2,521 kits
DistributionCanada, Singapore, New Zealand, Germany, Hong Kong, Japan, and Australia
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.
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