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U.S. Department of Health and Human Services

Class 3 Device Recall Elecsys

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  Class 3 Device Recall Elecsys see related information
Date Initiated by Firm December 07, 2005
Date Posted January 11, 2006
Recall Status1 Terminated 3 on February 26, 2006
Recall Number Z-0382-06
Recall Event ID 34273
PMA Number P990056S001 
Product Classification Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers - Product Code LTJ
Product Roche Elecsys total PSA CalSet, catalog number 11731696322.
Code Information Lot 171735.
Recalling Firm/
Manufacturer		 Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact
800-428-2336
Manufacturer Reason
for Recall		 There is the possibility of high results with sera expected to have non-detectable levels of tPSA if these reagent lots are used in combination on the Modular Analytics E170 analyzer.
FDA Determined
Cause 2		 Other
Action Consignees were notified of the incompatibility via reagent bulletin dated 12/7/05.
Quantity in Commerce 25,000 kits
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.
PMA Database PMAs with Product Code = LTJ and Original Applicant = ROCHE DIAGNOSTICS CORP.
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