Z-2809-2015Class II

MicroScan LabPro Information Manager System, Version 1.0 to Version 4.11, Catalog No. 10714149, 10714150...

Name: Z-2809-2015 MicroScan LabPro Information Manager System, Version 1.0 to Version 4.11, Catalog No. 10714149, 10714150...
Creator: Beckman Coulter Inc.
Published: 2015-07-17
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2015-07-17 / Terminated / root cause: software

FDA source

Beckman Coulter Inc. began a recall of MicroScan LabPro Information Manager System, Version 1.0 to Version 4.11, Catalog No. 10714149, 10714150. Intended to manage both microbial identification (ID)... on 2015-07-17. FDA classified it as Class II and gives the reason as "The software incorrectly allows the operator to manually edit the carbohydrate substrates when manually reading dried overnight gram negative panels with an ID Hold status". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2809-2015
Classification: Class II
Status: Terminated
Initiated: 2015-07-17
Posted: 2015-09-23
Terminated: 2018-01-04
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: MicroScan LabPro Information Manager System, Version 1.0 to Version 4.11, Catalog No. 10714149, 10714150. Intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST).
Product code: OUG Medical Device Data System
Reason for recall: The software incorrectly allows the operator to manually edit the carbohydrate substrates when manually reading dried overnight gram negative panels with an ID Hold status.
Root cause tag: software
FDA root cause: Unknown/Undetermined by firm
Action: An Urgent Medical Device Recall Letter dated 7/17/2015 was sent to all customers who purchased the MicroScan LabPro Information Manager System, Version 1.0 to Version 4.11. Beckman Coulter is recalling the MicroScan LabPro Information Manager System because the software incorrectly allows the operator to manually edit the carbohydrate substrates when manually reading dried overnight gram negative panels with an ID Hold status. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with questions are instructed to contact Customer Support Representative: http:www.beckmancoulter.com, (800) 677-7226 in US and Canada. Customers outside of US and Canada, are instructed to contact their local Beckman Coulter representative.
Quantity in commerce: 2,456 units total (1,034 units total)
Distribution: Worldwide distribution: United States (including Puerto Rico), Bahamas, Belgium, Canada, Chile, China, Colombia, France, French Guiana, Germany, Greece, Guadeloupe, India, Israel, Italy, Japan, Kazakhstan, Lithuania, Mexico, Netherlands, Panama, Paraguay, Poland, Portugal, Romania, Russia, Singapore, South Africa, Spain, Turkey, , US Virgin Islands, and Northern Mariana Islands, Uruguay.
Product codes and lots: Version 1.0 to Version 4.11

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2809-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2809-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-30	2015-09-23

Product code OUG

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)