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

FDA device recall Z-0455-05 · posted 2005-02-03 · Terminated

Recall details

Recalling firm

Becton Dickinson & Co.

Reason for recall

An in-vitro diagnostic kit reagent may cause false negative clinical results in patients tested for sexually transmitted infections.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

LSL

Quantity affected

2175 kits

Distribution

Product was distributed to direct accounts in the US and to affiliated distributors internationally.

Date initiated

2005-01-10

Date posted

2005-02-03

Date terminated

2005-04-19

Location

Sparks, MD