Recall Z-0247-2007 ยท LIE Reagent/Device, Inoculum Calibration
Dade Behring, Inc.
Dade Behring brand MicroScan Prompt Inoculation System-D; Catalog # B1026-10D;
| Date | Dec 5, 2006 (initiated Sep 27, 2006) |
| Status | Terminated |
| Reason | Product does not meet performance specifications through its standardized inocula for MicroScan Dried Gram-Negative and Gram-Positive Overnight panel testing. |
| Root cause | Other |
| Action | On 9/27/06, the firm initiated the recall and its notification was via phone calls and letters (FedEx''ed) explaining the reason for the recall and requesting the product be discarded. |
| Quantity | 828 units |
| Distribution | Worldwide, including USA, China, and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K820299 | PROMPT INOCULATION SYSTEM 3M Company, Mar 15, 1982 |