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U.S. Department of Health and Human Services

Class 3 Device Recall ARCHITECT Ferritin Reagent

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 Class 3 Device Recall ARCHITECT Ferritin Reagentsee related information
Date Initiated by FirmJune 06, 2006
Date PostedJuly 04, 2006
Recall Status1 Terminated 3 on January 18, 2008
Recall NumberZ-1204-06
Recall Event ID 35612
510(K)NumberK983759 
Product Classification Ferritin, Antigen, Antiserum, Control - Product Code DBF
ProductARCHITECT Ferritin Reagent; in vitro diagnostic; list numbers 6C11-20 (4 x 100 tests), 6C11-25 (1 x 100 tests) and 6C11-30 (4 x 500 tests); Abbott Laboratories, Abbott Park, IL 60064 USA
Code Information list numbers 6C11-20, 6C11-25 and 6C11-30; all lots
Recalling Firm/
Manufacturer		 Abbott Laboratories MPG
100 Abbott Park Rd
Abbott Park IL 60064-3502
Manufacturer Reason
for Recall		Some ARCHITECT Ferritin Reagent lots may not be meeting the accuracy by correlation to AxSYM claims as they are listed in the package insert (slope of 1.0 +/- 0.2).
FDA Determined
Cause 2		Other
ActionAbbott international affiliates were e-mailed copies of the recall letter on 6/6/06 for translation where needed and dissemination to their accounts receiving the affected product. The end users were advised that a shift in patient and/or control results occurs when changing to reagent and calibrator lots manufactured using the new internal reference standard, and that the accuracy by correlation between Architect and AxSYM Ferritin reagent lots does not match those stated in the package insert. The accounts advised to set new targets for their controls or use the enclosed targets in Attachment A when they change to the assay materials manufactured using the new internal reference standards. The accounts were requested to keep a copy of the letter on file until the revised package insert is received.
Quantity in Commerce10,725 kits
DistributionCanada, Germany, Uruguay, Japan, Singapore, Hong Kong, South Korea, Australia and New Zealand
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 = DBF
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