Z-1497-2012

MicroScan Dried Overnight Gram Negative Panels; Panel type: Neg Urine Combo 55; Catalog Number B1017-409...

Name: Z-1497-2012 MicroScan Dried Overnight Gram Negative Panels; Panel type: Neg Urine Combo 55; Catalog Number B1017-409...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2011-06-16
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2011-06-16 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of MicroScan Dried Overnight Gram Negative Panels; Panel type: Neg Urine Combo 55; Catalog Number B1017-409. Siemens Healthcare Diagnostics, West Sacramento, CA on 2011-06-16. The reason FDA records is "Three lots were confirmed to not meet performance claims due to random non-biological contamination which is only apparent (precipated) after inoculation of the panels". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1497-2012
Status: Terminated
Initiated: 2011-06-16
Posted: 2012-05-08
Terminated: 2012-05-08
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: MicroScan Dried Overnight Gram Negative Panels; Panel type: Neg Urine Combo 55; Catalog Number B1017-409. Siemens Healthcare Diagnostics, West Sacramento, CA.
Product code: JWY Manual Antimicrobial Susceptibility Test Systems
Reason for recall: Three lots were confirmed to not meet performance claims due to random non-biological contamination which is only apparent (precipated) after inoculation of the panels.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Customer Notification letters were sent to all customers of the three MicroScan panels by traceable mail. The letter identified the affected product and asked customers to discard any remaining inventory in addition to contacting customer service for replacement product. The letter also recommended that customers consider the need to review previous test results, conduct patient follow-up, and or repeat tests as needed. Customers were to complete and return the customer reply card to confirm that they received and understood the recall communication.
Quantity in commerce: 687 boxes (20 panels per box).
Distribution: Worldwide Distribution -- US, Turkey, Poland, and Great Britain.
Product codes and lots: lot code 2011-06-09.

Product code JWY

K862140Class IIMicrodilution PanelsAmerican Micro Scan / cleared 1986-07-16

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)