Z-0541-2009

MicroScan Synergies Plus Negative Panels, 20 panels per box Medical device designed for use in determining...

Name: Z-0541-2009 MicroScan Synergies Plus Negative Panels, 20 panels per box Medical device designed for use in determining...
Creator: Siemens Microscan
Published: 2008-07-31
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2008-07-31 / Terminated

FDA source

Siemens Microscan began a recall of MicroScan Synergies Plus Negative Panels, 20 panels per box Medical device designed for use in determining quantitative and/or qualitative antimicrobial agent... on 2008-07-31. The reason FDA records is "Falsely lowered imipenem MICs may result, leading to major errors in results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0541-2009
Status: Terminated
Initiated: 2008-07-31
Posted: 2009-02-04
Terminated: 2010-11-29
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: MicroScan Synergies Plus Negative Panels, 20 panels per box Medical device designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification to the species level of colonies, grown on solid media, of rapidly growing aerobic and facultative anaerobic gram-negative bacteria. Catalog Nos. B1016-200, B1016-201, B1016-202, B1016-203, B1025-103, B1025-104, B1025-105, B1025-106, B1025-107, B1025-108, B1025-109, B1025-112, and B1027-101
Product code: JWY Manual Antimicrobial Susceptibility Test Systems
Reason for recall: Falsely lowered imipenem MICs may result, leading to major errors in results.
FDA root cause: Other
Action: Consignees were notified on July 31, 2008 by letter (Urgent Device Correction) sent via FedEx overnight. International consignees were notified by Siemens Healthcare Diagnostics associates in affected countries. The letter described the problem and provided users with safety instructions to follow until an update is provided. Contact Siemens Healthcare Diagnostics Inc. at 916-374-3075 for additional assistance.
Quantity in commerce: Total of both Negative and Synergy: 569,375 boxes
Distribution: Worldwide
Product codes and lots: All lots

Product code JWY

K870074Class IIGram Negative and Gram Positive Mic/combo PanelsMicroscan Div. Baxter Healthcare Corp. / cleared 1987-04-14

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)