Z-0668-05

MicroScan Rapid Pos Inoculum Broth, Catalog #: B1015-14; Manufactured and distributed by: Dade Behring Inc...

Name: Z-0668-05 MicroScan Rapid Pos Inoculum Broth, Catalog #: B1015-14; Manufactured and distributed by: Dade Behring Inc...
Creator: Dade Behring
Published: 2005-02-07
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2005-02-07 / Terminated

FDA source

Dade Behring began a recall of MicroScan Rapid Pos Inoculum Broth, Catalog #: B1015-14; Manufactured and distributed by: Dade Behring Inc. 2040 Enterprise Blvd. West Sacramento, CA 95691 on 2005-02-07. The reason FDA records is "There is a potential for reporting of false susceptible anti-microbic results that could result in inappropriate and/or less effective therapy". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0668-05
Status: Terminated
Initiated: 2005-02-07
Posted: 2005-04-06
Terminated: 2005-07-05
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: MicroScan Rapid Pos Inoculum Broth, Catalog #: B1015-14; Manufactured and distributed by: Dade Behring Inc. 2040 Enterprise Blvd. West Sacramento, CA 95691
Product code: LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Reason for recall: There is a potential for reporting of false susceptible anti-microbic results that could result in inappropriate and/or less effective therapy.
FDA 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 in commerce: 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.
Product codes and lots: Lot Nos.: 050905A-1, 051005A-1, 051605A-1, 051705A-1, 052305A-1, 052805B-1

Product code LON

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)