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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm December 03, 2004
Date Posted January 06, 2005
Recall Status1 Terminated 3 on September 08, 2005
Recall Number Z-0383-05
Recall Event ID 30563
510(K)Number K000784  
Product Roche brand Cardiac Reader.
Code Information All units.
Recalling Firm/
Manufacturer		 Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact
800-428-2336
Manufacturer Reason
for Recall		 Potential for false negative Troponin T or falsely decreased Troponin T and Myoglobin results.
FDA Determined
Cause 2		 Other
Action User hospitals were notified via phone, letter and fax (beginning on 12/3/04) a copy of the recall notification on December 3, 2004, which instructed them to immediately cease using the device. The firm issued a press release on December 8, 2004.
Quantity in Commerce 95
Distribution United States.
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 = and Original Applicant = ROCHE DIAGNOSTICS CORP.
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