Z-1528-2015Class II

MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for...

Name: Z-1528-2015 MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for...
Creator: Beckman Coulter, Inc.
Published: 2014-08-08
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2014-08-08 / Terminated / root cause: labeling and UDI

FDA source

Beckman Coulter, Inc. began a recall of MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg... on 2014-08-08. FDA classified it as Class II and gives the reason as "Technical Support Bulletin issued in February 2013 did not mention performance limitation for Proteus mirabilis and Imp when using the CLSIM100-S20 revised interpretive criteria". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1528-2015
Classification: Class II
Status: Terminated
Initiated: 2014-08-08
Posted: 2015-04-27
Terminated: 2015-04-27
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg Combo 50, Catalog B1017-406 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.
Product code: JWY Manual Antimicrobial Susceptibility Test Systems
Reason for recall: Technical Support Bulletin issued in February 2013 did not mention performance limitation for Proteus mirabilis and Imp when using the CLSIM100-S20 revised interpretive criteria.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: The firm, Siemens, sent an "Urgent Medical Device Correction" letter dated August 7, 2014 to affected customers by trackable method. The letter describe product, problem and actions to be taken. The customers were instructed to confirm receipt of the letter; complete the attached "Field Correction Effectiveness Check" form via fax to Siemens Healthcare Diagnostics at 302-631-8467;TSB 190 has been removed from use and archived from the Siemens Document Library, if you have a hardcopy, discard it appropriately;and follow the listed in instructions and retain and forward this letter to those who may have received this product. If you have any questions, please contact your Siemens Customer Care Center; Quality Systems & Compliance Director at 916-374-3031 or email: [email protected] or your local Siemens technical support representative.
Quantity in commerce: Approx ~(216240 boxes U.S. and 84249 boxes OUS) total
Distribution: Worldwide Distribution: US (Nationwide) and to countries of: Argentina, Bahamas, Brazil, Canada, China, Ecuador, Egypt, Germany, Lithuania, Mexico, Paraguay, Peru Poland, Portugal, Romania, Russian Federation, Singapore, South Africa, Spain, Taiwan, Thailand, Trinidad and Tobago, United Arab Emirates, Uruguay, and Venezuela.
Product codes and lots: Catalog number: B1017-406; Siemens Material Number (SMN): 10444700.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1528-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1528-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-06	2015-04-27
Z-1529-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-06	2015-04-27
Z-1530-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-06	2015-04-27
Z-1531-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-06	2015-04-27
Z-1532-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-06	2015-04-27
Z-1533-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-06	2015-04-27
Z-1534-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-06	2015-04-27

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