Recall Z-1215-2013 ยท JTY Culture Media, For Isolation Of Pathogenic Neisseria
Becton Dickinson & Co.
BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack, REF 441124, contains 12 each Microwells labeled in part ***BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack REF 441124 ***For use with the BD Viper System *** Becton, Dickinson and Company 7 Loveton Circle, Sparks, MD 21152 USA www.bd.com/ds EC REP Benex Limited, Pottery Road, Dun Laoghaire, Co. D
| Date | May 3, 2013 (initiated Feb 8, 2013) |
| Status | Terminated |
| Reason | Increased levels of false positives in BD Probe Tech Neisseria gonorrhoeae Q Amplified DNA assay kits. |
| Root cause | Environmental control |
| Action | BD Diagnostic Systems sent an "URGENT PRODUCT RECALL" letter via UPS overnight delivery on February 8, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to verify that these kits have been consumed, returned or destroyed by completing the enclosed form. The firm will issue a no charge replacement for customers' product. Any product remaining in customers' inventory should be discarded or destroyed per their facility procedures. Complete the attached form regardless if any inventory remains, so that the firm may ackno |
| Quantity | 77 kits |
| Distribution | Distributed in the states of CA, FL, GA, NJ, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081825 | BD PROBETEC NEISSERIA GONORRHOEAE (GC) Q AMPLIFIED DNA ASSAY Becton, Dickinson & CO, Dec 11, 2008 |
| K090827 | BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY Becton, Dickinson & CO, May 27, 2009 |
| K090971 | BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY Becton, Dickinson & CO, Jun 5, 2009 |
| K091730 | BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY Becton, Dickinson & CO, Nov 13, 2009 |