Recall Z-1799-2013 ยท JSJ Culture Media, Selective And Non-Differential
Becton Dickinson & Co.
BD BBL Schaedler K-V Agar with 5% Sheep Blood, carton of 20 plates, catalog # 221555, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Vancomycin Screen Agar is used to test entercocci for resistance to vancomycin and to predict the synergistic activity of this antimicrobial with an aminoglycoside antimicrobial.
| Date | Jul 24, 2013 (initiated Jun 6, 2013) |
| Status | Terminated |
| Reason | Microbiological identification media may exhibit reduced levels of Vancomycin. |
| Root cause | Nonconforming Material/Component |
| Action | The firm, BD Diagnostic Systems, sent an "URGENT PRODUCT RECALL" letter dated June 2013 to Distributors by fax, US customers via letters by UPS and OUS BD sites via email and teleconference. The letter described the product, problem and actions to be taken. All customers were instructed to discontinue use of the listed product; discard any remaining packages, and complete and return the attached form, whether or not you have any inventory remaining, via Fax to: Attention: Regulatory Compliance, 410-316-4258. BD will issue replacements for the discarded material. It is not necessary to conta |
| Quantity | 92 cartons |
| Distribution | Worldwide distribution: US (nationwide) and countries of:Belgium, Canada, Columbia, Mexico, Singapore, and Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K760460 | SCHAEDLER SELECTIVE AGAR-KV Bd Becton Dickinson Vacutainer Systems Preanalytic, Sep 3, 1976 |