Recall Z-1816-2015 ยท OOI Real Time Nucleic Acid Amplification System
Becton Dickinson & Co.
BD Viper LT System, catalog number 442839 when used in conjunction with the BD ProbeTec Chlamydia trachomatis (CT) Qx Assay (cat. #442959) and the BD ProbeTec Neisseria gonorrhoeae (GC) Qx Assay (cat. #442842). In vitro diagnostic.
| Date | Jun 18, 2015 (initiated Nov 7, 2014) |
| Status | Terminated |
| Reason | Potential for false positive Chlamydia trachomatis (CT) results and Neisseria gonorrhoeae (GC) results when processing the CT Qx and GC Qx Assays on the BD Viper LT Instrument. |
| Root cause | Device Design |
| Action | BD sent an Urgent Field Corrective Action letter dated November 2014, to all affected customers. The letter identified the problem the product and the action needed to be taken by the customer. Customers were advised: a. Include the date recall was initiated, if it is already underway or the date your firm plans to start the recalling process. b. How do you plan to notify all the consignees affected by this recall? (press release, letter, telefax, telephone, e-mail, visit, etc.) The customer was initially contacted via a phone call and subsequently provided with a written communica |
| Quantity | 7 Viper LT Systems |
| Distribution | Worldwide distribution to US (state of LA), Hong Kong, Austria, China, France, and the UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140447 | BD VIPER LT SYSTEM Becton, Dickinson and Company, May 20, 2014 |