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U.S. Department of Health and Human Services

Class 2 Device Recall Dimension TSPA Flex Reagent Cartridge

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 Class 2 Device Recall Dimension TSPA Flex Reagent Cartridgesee related information
Date Initiated by FirmApril 21, 2003
Date PostedMay 29, 2003
Recall Status1 Terminated 3 on July 31, 2003
Recall NumberZ-0873-03
Recall Event ID 26195
PMA NumberP000021 
Product Classification Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers - Product Code LTJ
ProductDimension TSPA (Total Prostate Specific Antigen) Flex Reagent Cartridge. The product is shipped 4 cartridges per carton.
Code Information Product code number RF451. Lot number CD4085 exp 3/25/04
Recalling Firm/
Manufacturer		 Dade Behring Inc
Rte 896, Glasgow Business Community
Newark DE 19702
For Additional Information ContactRobin Norris
302-631-6000
Manufacturer Reason
for Recall		test results may be inaccurate by 0.2 to 0.5 ng/mL
FDA Determined
Cause 2		Other
ActionThe recalling firm telephone each customer on 4/24-28/03 to determine if any customer used the lot (CD4085). If so, the customer was instructed to retest all samples with an alternate lot. All customers were instructed to discard any remaining inventory. As a follow up to the phone calls, the recalling firm issued a recall letter dated 4/25/03 informing the customer of the problem and to discard any remaining product.
Quantity in Commerce662 cartons
DistributionThe product was shipped to hospitals and clinic laboratories nationwide. There are eight government/military accounts; one of which is foreign.
Total Product Life CycleTPLC 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 DatabasePMAs with Product Code = LTJ
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