Z-0455-05

BD ProbeTec ET Urine Processing Kit, 4x25, catalog 440454, packaged in a carton containing 4 storage bags...

Name: Z-0455-05 BD ProbeTec ET Urine Processing Kit, 4x25, catalog 440454, packaged in a carton containing 4 storage bags...
Creator: Becton Dickinson & Co.
Published: 2005-01-10
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2005-01-10 / Terminated

FDA source

Becton Dickinson & Co. began a recall of BD ProbeTec ET Urine Processing Kit, 4x25, catalog 440454, packaged in a carton containing 4 storage bags identified as BD ProbeTec ET Urine Processing... on 2005-01-10. The reason FDA records is "An in-vitro diagnostic kit reagent may cause false negative clinical results in patients tested for sexually transmitted infections". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0455-05
Status: Terminated
Initiated: 2005-01-10
Posted: 2005-02-03
Terminated: 2005-04-19
Recalling firm: Becton Dickinson & Co
Product: BD 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***
Product code: LSL Dna-Reagents, Neisseria
Reason for recall: An in-vitro diagnostic kit reagent may cause false negative clinical results in patients tested for sexually transmitted infections.
FDA root cause: Other
Action: BD 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 commerce: 2175 kits
Distribution: Product was distributed to direct accounts in the US and to affiliated distributors internationally.
Product codes and lots: 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

Product code LSL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)