Date Initiated by Firm |
March 24, 2008 |
Date Posted |
June 28, 2008 |
Recall Status1 |
Terminated 3 on October 15, 2008 |
Recall Number |
Z-1606-2008 |
Recall Event ID |
47518 |
PMA Number |
P000021 |
Product Classification |
Total Prostate Specific Antigen - Product Code MTF
|
Product |
Dimension Total Prostate Specific Antigen (TPSA) Flex Reagent Cartridge (RF451). Siemens, Newark, DE 19714 |
Code Information |
Lot number GB9021 exp 2009-01-21 and Lot number GB9029 exp 2009-01-29 |
Recalling Firm/ Manufacturer |
Siemens Healthcare Diagnostics Inc. 500 GBC Drive, Mailstop 514 P. O. Box 6101 Newark DE 19714-6101
|
For Additional Information Contact |
Elaine Kindell 302-631-6564
|
Manufacturer Reason for Recall |
False Results: The product may exhibit falsely elevated results. The affected lots demonstrate sporadic variability in recovery of calibrator and quality control; therefore this issue may not be readily detected upon calibration or during routine processing of Quality Control.
|
FDA Determined Cause 2 |
Device Design |
Action |
The recalling firm issued a letter (Urgent Field Safety Notice) dated 3/25/08 to inform their customers to discontinue use of any remaining inventory, retest using an alternate lot for those samples from post-prostatectomy patients which recovered positive TPSA results less than 1.0 ng/nL. The firm has requested that you call the them for no-charge replacement product at 1-800-441-9250 and/or for technical assistance. |
Quantity in Commerce |
1631 cartons |
Distribution |
The product was shipped to medical facilities nationwide. The product was also shipped to Germany, Singapore, Canada, Japan and AE |
Total Product Life Cycle |
TPLC Device Report
|
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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.
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PMA Database |
PMAs with Product Code = MTF and Original Applicant = SIEMENS HEALTHCARE DIAGNOSTICS
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