Recall Z-0455-05 ยท LSL Dna-Reagents, Neisseria
Becton Dickinson & Co.
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***
| Date | Feb 3, 2005 (initiated Jan 10, 2005) |
| Status | Terminated |
| Reason | An in-vitro diagnostic kit reagent may cause false negative clinical results in patients tested for sexually transmitted infections. |
| 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 ad |
| Quantity | 2175 kits |
| Distribution | Product was distributed to direct accounts in the US and to affiliated distributors internationally. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.