Recall Z-2658-2011 ยท MKZ Dna Probe, Nucleic Acid Amplification, Chlamydia
Becton Dickinson & Co.
BD ProbeTec" CT/GC/AC Reagent Pack, catalog #440450, labeled in part ***Becton Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152*** The BD ProbeTec" ET Chlamydia trachomatis and Neisseria gonorrhoeae Amplified DNA Assays, when tested with the BD ProbeTec ET System, use Strand Displacement Amplification (SDA) technology for the direct, qualitative detection of Chlamydia trachomatis and Ne
| Date | Jun 24, 2011 (initiated Sep 29, 2010) |
| Status | Terminated |
| Reason | In vitro diagnostic reagent packs may be underfilled and contribute to invalid quality control testing or false positive patient results. |
| Root cause | Process control |
| Action | BD Diagnostic Systems sent an "URGENT PRODUCT RECALL" letter dated September 2010 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. Customers were instructed to discontinue use of the product and discard any remaining product. BD will replace any discarded products. Additionally, customers were requested to complete and return an attached form whether or not they have any inventory remaining, to confirm receipt of the notification. The letter instructed the customers to fax the completed form to: Attention: Regulatory Compl |
| Quantity | 130 kits |
| Distribution | Worldwide Distribution--USA (nationwide) including the states of AL, CA, CO, CT, FL, GA, KY, LA, ME, MN, MO, MS, MT, NE, OH, PA, RI, TX, and WA and the countries of Australia, Canada, Europe, and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K984631 | BDPROBETEC ET CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE AMPLIFIED DNA ASSAY Becton Dickinson Microbiology Systems, Nov 4, 1999 |