Z-0171-2015Class I

Rapid Neg Urine Combo Panel Type 1; Catalog number B 1017-167; Siemens Material Number 10444652 MicroScan...

Name: Z-0171-2015 Rapid Neg Urine Combo Panel Type 1; Catalog number B 1017-167; Siemens Material Number 10444652 MicroScan...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2014-10-17
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2014-10-17 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Rapid Neg Urine Combo Panel Type 1; Catalog number B 1017-167; Siemens Material Number 10444652 MicroScan Rapid panels are designed for use in determining... on 2014-10-17. FDA classified it as Class I and gives the reason as "An increase in false positive susceptible results on Rapid Neg BP Combo Panel Type 3 and Rapid Neg Urine Combo Panel Type 1 used with MicroScan Microbiology Systems". 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-0171-2015
Classification: Class I
Status: Terminated
Initiated: 2014-10-17
Posted: 2014-11-07
Terminated: 2015-06-29
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Rapid Neg Urine Combo Panel Type 1; Catalog number B 1017-167; Siemens Material Number 10444652 MicroScan Rapid panels are designed for use in determining identification to the species level and/or antimicrobial agent susceptibility of rapidly growing aerobic and facultatively anaerobic gram negative bacilli.
Product code: LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Reason for recall: An increase in false positive susceptible results on Rapid Neg BP Combo Panel Type 3 and Rapid Neg Urine Combo Panel Type 1 used with MicroScan Microbiology Systems.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Customer Recall notification letters were sent on October 17, 2014. Letters recommend that any remaining inventory be discarded and that consideration be given to reviewing previous test result, conduct patient follow up and/or repeat testing if isolates are still available. A second letter clarifying the recall was issued November 7, 2014 which provided additional information as requested by CDRH.
Quantity in commerce: 2239
Distribution: Distributed US (nationwide) including the states of IA, CA, NY, WI, MI, SD, NC, FL, HI, OH, WA, TX, WA, IN, NM, MS, KY, IL, UT, ND, and WY and the country of Canada.
Product codes and lots: Catalog number: B1017-167, Siemens Material number 1044652, lot numbers: 2014-11-01, Exp. 2014-11-01; 2015-01-03, Exp 2015-01-03; 2015-02-14, Exp 2015-02-14; 2015-03-21, Exp 2015-03-21; 2015-05-20, Exp 2015-05-20; 2015-06-18, Exp 2015-06-18; 2015-07-18, Exp 2015-07-18; 2015-08-11, Exp 2015-08-11/

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0171-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0170-2015	Class I	Terminated	Voluntary: Firm initiated	2014-11-19	2014-11-07
Z-0171-2015	Class I	Terminated	Voluntary: Firm initiated	2014-11-19	2014-11-07

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)