Z-0247-2007

Dade Behring brand MicroScan Prompt Inoculation System-D; Catalog # B1026-10D

Name: Z-0247-2007 Dade Behring brand MicroScan Prompt Inoculation System-D; Catalog # B1026-10D
Creator: Dade Behring, Inc.
Published: 2006-09-27
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2006-09-27 / Terminated

FDA source

Dade Behring, Inc. began a recall of Dade Behring brand MicroScan Prompt Inoculation System-D; Catalog # B1026-10D on 2006-09-27. The reason FDA records is "Product does not meet performance specifications through its standardized inocula for MicroScan Dried Gram-Negative and Gram-Positive Overnight panel testing". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0247-2007
Status: Terminated
Initiated: 2006-09-27
Posted: 2006-12-05
Terminated: 2006-12-28
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Dade Behring brand MicroScan Prompt Inoculation System-D; Catalog # B1026-10D;
Product code: LIE Reagent/Device, Inoculum Calibration
Reason for recall: Product does not meet performance specifications through its standardized inocula for MicroScan Dried Gram-Negative and Gram-Positive Overnight panel testing.
FDA 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 in commerce: 828 units
Distribution: Worldwide, including USA, China, and Germany.
Product codes and lots: Lot Numbers: 20071127, 20071128

Product code LIE

K820299Class IIPrompt Inoculation System3M Company / cleared 1982-03-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)