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U.S. Department of Health and Human Services

Class 2 Device Recall Dimension Total Prostate Specific Antigen Flex Reagent Cartridge

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  Class 2 Device Recall Dimension Total Prostate Specific Antigen Flex Reagent Cartridge see related information
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
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 = MTF and Original Applicant = SIEMENS HEALTHCARE DIAGNOSTICS
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