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U.S. Department of Health and Human Services

Class 2 Device Recall COBAS Integra DIG

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  Class 2 Device Recall COBAS Integra DIG see related information
Date Initiated by Firm March 16, 2007
Date Posted April 13, 2007
Recall Status1 Terminated 3 on June 12, 2008
Recall Number Z-0736-2007
Recall Event ID 37599
510(K)Number K851032  
Product Classification Digoxin Reagent - Product Code KXT
Product Roche COBAS Integra DIG, Digoxin Reagent for use on the COBAS INTEGRA models 400, 400 plus, 700 and 800 analyzers, as well as, Cobas c 501 analyzer; Catalog Number 20737836322.
Code Information All Reagent Lots (including Lots 67941901, exp. 4/30/07; 68139201, exp. 6/30/07 and 68156201, exp. 8/31/07)
Recalling Firm/
Manufacturer
Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact
800-428-2336
Manufacturer Reason
for Recall
The lower detection limit (LDL) may be a higher value than stated in the labeling. Note: To resolve this issue, the Digoxin LDL claim has been revised to 0.3 ng/mL for all reagent lots.
FDA Determined
Cause 2
Other
Action A recall letter dated 3/16/07 was sent to each consignee advising them that the LDL claim in the label has been revised to 0.3 ng/ml for all reagent lots.
Quantity in Commerce 4,735
Distribution Nationwide.
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 = KXT and Original Applicant = ROCHE DIAGNOSTIC SYSTEMS, INC.
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