Z-2122-2013Class I

Microscan Synergies Plus Negative Urine Combo 2

Name: Z-2122-2013 Microscan Synergies Plus Negative Urine Combo 2
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2013-08-21
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2013-08-21 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Microscan Synergies Plus Negative Urine Combo 2 Product Usage: MicroScan Synergies plus Panels & MicroScan Rapids plus (Negative) - For use in determining... on 2013-08-21. FDA classified it as Class I and gives the reason as "Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System". 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-2122-2013
Classification: Class I
Status: Terminated
Initiated: 2013-08-21
Posted: 2013-09-11
Terminated: 2014-05-15
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Microscan Synergies Plus Negative Urine Combo 2 Product Usage: MicroScan Synergies plus Panels & MicroScan Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria.
Product code: LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Reason for recall: Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Siemens sent an Urgent Field Safety Notice letters dated August 2013 to all US customers via over night delivery, receipt requested. Letters for foreign customers are being translated and will be sent as soon as possible. The letter identified the affected product, reason for field correction, risk to health problem and actions to be taken by customer. Customers were instructed to suppress all reporting of sensitive and intermediate results for imipenem and meropenem. Siemens also recommends that the customer consider the need to review previous test results, conduct patient follow-up, and/or repeat testing. Customer were requested to complete the attached Field Correction Effectiveness Check form and fax it to 302-631-8467. For questions contact your Siemens Technical Support Provider or Distributor.
Quantity in commerce: 1,324 boxes, 26,480 panels
Distribution: Worldwide Distribution - USA Nationwide in the states of: AK, SC, IA, MO GA, WI, TX, KS, CA, IL, CO, AZ, SD, IN, MD, FL, MN and the countries of:Japan, France, Algeria, Germany, Austria, Romania, Russian Federation, South Africa, Kazakhstan, Belgium, Great Britain, Turkey, Spain, Italy, Saudi Arabia, Qutar, Poland, Iraq, Unite Arab Emrites, Algeria, Oman, Greece, Portugal, and Ireland.
Product codes and lots: Internal Number - B1025-112 Catalog Number - 10444749 Lot code/expiration date: 2012-07-12, 2012-07-12; 2012-10-03, 2012-10-03; 2013-06-08, 2013-06-08; 2013-12-17, 2013-12-17; 2014-04-22, 2014-04-22; 2014-06-11, 2014-06-11;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2122-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2119-2013	Class I	Terminated	Voluntary: Firm initiated	2013-09-18	2013-09-11
Z-2120-2013	Class I	Terminated	Voluntary: Firm initiated	2013-09-18	2013-09-11
Z-2121-2013	Class I	Terminated	Voluntary: Firm initiated	2013-09-18	2013-09-11
Z-2122-2013	Class I	Terminated	Voluntary: Firm initiated	2013-09-18	2013-09-11
Z-2123-2013	Class I	Terminated	Voluntary: Firm initiated	2013-09-18	2013-09-11
Z-2124-2013	Class I	Terminated	Voluntary: Firm initiated	2013-09-18	2013-09-11
Z-2125-2013	Class I	Terminated	Voluntary: Firm initiated	2013-09-18	2013-09-11
Z-2126-2013	Class I	Terminated	Voluntary: Firm initiated	2013-09-18	2013-09-11
Z-2127-2013	Class I	Terminated	Voluntary: Firm initiated	2013-09-18	2013-09-11
Z-2128-2013	Class I	Terminated	Voluntary: Firm initiated	2013-09-18	2013-09-11
Z-2129-2013	Class I	Terminated	Voluntary: Firm initiated	2013-09-18	2013-09-11

Product code LON

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)