Recall Z-0976-2013 ยท NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Becton Dickinson & Co.
BD MAX PCR Cartridges Catalog #437519, box of 24 cartridges labeled in part:***BD MAX PCR Cartridges, GeneOhm Sciences Canada, Inc. 2555 boul du Parc-Technologique, Quebec, Canada G1P 4S5***BD Max Group B Streptococcus (GBS) Assay is an in vitro diagnostic (IVD) test for detection of GBS DNA in Lim Broth cultures. The BD MAX" PCR Cartridge is a consumable required for the BD MAX" System.
| Date | Mar 22, 2013 (initiated Dec 11, 2012) |
| Status | Terminated |
| Reason | Cartridges are not sealing properly during PCR testing and may cause false results, indeterminates and/or invalid runs. |
| Root cause | Process control |
| Action | BD Diagnostic Systems issued an Urgent Product Recall letter via UPS delivery on December 11, 2012. The letter identified the product, the problems, and the action to be taken by the customer. Customers were instructed to take the following actions: Discontinue and discard any affected product. BD would send replacements for the discarded material. Complete the attached form whether or not they have any inventory remaining so that the firm may acknowledge their receipt of the notification. Fax the form to: Attention: Regulatory Compliance, Fax: 410-316-4258 or Email to RegulatoryComplian |
| Quantity | 27 boxes/648 cartridges |
| Distribution | Worldwide Distribution - USA including CA, FL, IN, IL, KS, NY, OH, OR, PA, TX, and WI and the country of Belgium |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111860 | BD MAX GBS ASSAY, BD MAX INSTRUMENT Becton, Dickinson & CO, Feb 16, 2012 |