Recall Z-0668-05 ยท LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Dade Behring
MicroScan Rapid Pos Inoculum Broth, Catalog #: B1015-14; Manufactured and distributed by: Dade Behring Inc. 2040 Enterprise Blvd. West Sacramento, CA 95691
| Date | Apr 6, 2005 (initiated Feb 7, 2005) |
| Status | Terminated |
| Reason | There is a potential for reporting of false susceptible anti-microbic results that could result in inappropriate and/or less effective therapy. |
| Root cause | Other |
| Action | The customer notifications were sent to U.S. customers on January 27, 2005 via FedEx. International customers are to be notified by Dade Behring affiliates in the affected countries by February 10, 2005. Follow up will be made via phone call. |
| Quantity | 324 boxes |
| Distribution | 71 consignees including customers in U.S., Puerto Rico and distributors. Number of international customers to be determined at completion of effectiveness check. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.