Recall Z-3219-2011 ยท NQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
Becton Dickinson & Co.
BD MAX RNA Extraction Kit RNA-3, Catalog Number 437506. Kit contains 24/2D barcode sample preparation reagent tubes. The BD MAX RNA Extraction Kit is used with the BD MAX System to extract RNA from viruses which maybe present in clinical specimens. Purified RNA obtained with the BD MAX System or another commercially available system for reverse transcription followed by nucleic acid amplificati
| Date | Sep 16, 2011 (initiated May 24, 2011) |
| Status | Terminated |
| Reason | Sample results maybe switched between time it was scanned with handheld barcode reader and time it was placed in the sample rack, associating sample results to wrong patient. |
| Root cause | Nonconforming Material/Component |
| Action | BD Diagnostic Systems sent an "URGENT PRODUCT RECALL" letter dated May 2011, to all affected customers. The letter identified the products, the problem, and the action to be taken by the customers. The letter advised customers to discontinue use of the Sample Preparation Reagent tubes in the referenced kits and discard any remaining products. Customers were requested to complete an attached reply form to acknowledge their receipt of the notification and fax it to (410) 316-4258. For further assistance regarding replacements contact BD Customer Service Dept. 1-800-675-0908. For all other i |
| Quantity | 138 kits |
| Distribution | Worldwide Distribution-USA (nationwide) including the states of CA, KY, MD, MI, NC, NY, TX, and WI and the country Belgium. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.