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U.S. Department of Health and Human Services

Class 1 Device Recall

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 Class 1 Device Recallsee related information
Date Initiated by FirmJanuary 10, 2005
Date PostedFebruary 03, 2005
Recall Status1 Terminated 3 on April 19, 2005
Recall NumberZ-0455-05
Recall Event ID 30844
Product Classification Dna-Reagents, Neisseria - Product Code LSL
ProductBD ProbeTec ET Urine Processing Kit, 4x25, catalog 440454, packaged in a carton containing 4 storage bags identified as BD ProbeTec ET Urine Processing Pouches, 25 pouches/bag. Carton and bags labeled in part ***Becton, Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152***
Code Information Lot/Exp 4103719 October 31, 2005 4118463 October 31, 2005 4119670 November 30, 2005 4124224 November 30, 2005 4133122 November 30, 2005 4105126 October 31, 2005 4118129 November 30, 2005 4104256 October 31, 2005 4091913 October 31, 2005 4104254 October 31, 2005 4090438 October 31, 2005 4090259 October 31, 2005 4084784 October 31, 2005 4014879 July 31, 2005 4016963 July 31, 2005 4023837 July 31, 2005 4023840 August 31, 2005 4041551 August 31, 2005 4083445 October 31, 2005 4133902 November 30, 2005 
FEI Number 1119779
Recalling Firm/
Manufacturer		 Becton Dickinson & Co.
7 Loveton Cir
Sparks MD 21152-9212
For Additional Information ContactBD Technical Service
800-666-6433 Ext. 4331
Manufacturer Reason
for Recall		An in-vitro diagnostic kit reagent may cause false negative clinical results in patients tested for sexually transmitted infections.
FDA Determined
Cause 2		Other
ActionBD notified consignees by phone on 01/10/05 and advised that users transporting patient urine samples may experience increased indeterminate results or false negative results when testing the samples on the BD ProbeTec ET CT/GC Amplified DNA Assay. Subsequest to the phone notification, kit users identified as utilizing the Urine Processing Pouches were further notified by a letter. The letter describes 4 criteria contributing to the risk associated with false negative and indeterminate results. The letter advised users to discontinue use of the kits and discard for replacement. BD further advised in the notification that if the user is not utilizing the Amplification Control (AC), the firm recommends that they evaluate if urine specimens were transported and/or stored at refrigerated temperatures in the kit''s urine pouches. If specimens were transported and/or stored under the noted criteria, BD recommends that users should notify physicians who received reports of negative patient results and indicate that there is a possibility that these results were incorrect. BD plans to provide a 'Dear Physician' letter that would facilitate that notification upon request of the users.
Quantity in Commerce2175 kits
DistributionProduct was distributed to direct accounts in the US and to affiliated distributors internationally.
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.
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