Class 2 Device Recall COBAS Integra DIG

• Date Initiated by Firm: March 16, 2007
• Date Posted: April 13, 2007
• Recall Status: Terminated 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: 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