Dade Behring brand MicroScan Prompt Inoculation System-D; Catalog # B1026-10D;
FDA Recall Z-0247-2007 · Posted 2006-12-05
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Recalling FirmDade Behring, Inc.
Recall StatusTerminated
Product CodeLIE
Date Initiated2006-09-27
Date Terminated2006-12-28
Product Quantity828 units
Reason for Recall
Product does not meet performance specifications through its standardized inocula for MicroScan Dried Gram-Negative and Gram-Positive Overnight panel testing.
Firm 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.
Root Cause
Other
Distribution Pattern
Worldwide, including USA, China, and Germany.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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