Date Initiated by Firm |
December 07, 2005 |
Date Posted |
January 11, 2006 |
Recall Status1 |
Terminated 3 on February 26, 2006 |
Recall Number |
Z-0381-06 |
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, catalog number 11731262322. |
Code Information |
Lot 171640. |
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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