Z-1269-2016Class II

MicroScan LabPro Information Manager System, Software Versions 1.0 to 4.41 Catalog No. 10638819, 10638820...

Name: Z-1269-2016 MicroScan LabPro Information Manager System, Software Versions 1.0 to 4.41 Catalog No. 10638819, 10638820...
Creator: Beckman Coulter Inc.
Published: 2016-02-11
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2016-02-11 / Terminated / root cause: software

FDA source

Beckman Coulter Inc. began a recall of MicroScan LabPro Information Manager System, Software Versions 1.0 to 4.41 Catalog No. 10638819, 10638820, 10638823, 10638824, 10638825,10638826... on 2016-02-11. FDA classified it as Class II and gives the reason as "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...". 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-1269-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-11
Posted: 2016-03-28
Terminated: 2018-01-04
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: MicroScan LabPro Information Manager System, Software Versions 1.0 to 4.41 Catalog No. 10638819, 10638820, 10638823, 10638824, 10638825,10638826, 10714149,10714159, 10805072, 10805073, 10975000, 10975001, 6000-0008, 6000-0026. Japan: 10638819 LabPro v4.11 Software Update Kit 10638820 LabPro v4.11 System Software 10805072 LabPro MBT Non-Connect Systems v4.30 10805073 LabPro MBT Connect Systems v4.30 Canada: 6000-0008 LabPro v4.41 Panel Update-06 Kit 6000-0026 LabPro Connect v4.41 Panel Update-06 Kit 10638823 LabPro v4.11 Software Update Kit 10638825 LabPro v4.11 System Software 10638824 LabPro v4.11 Software Update Kit Europe: 10638824 LabPro v4.11 Software Update Kit 10638826 LabPro v4.11 System Software USA: 10714149, LabPro v4.11 Software Update Kit 10714150 LabPro v4.11 System Software 10975000 ASM LabPro-MBT v4.40 10975001 ASM LabPro-MBT v4.40 for Connect 6000-0008 LabPro v4.41 Panel Update-06 Kit 6000-0026 LabPro Connect v4.41 Panel Update-06 Kit ROW: 6000-0008 LabPro v4.41 Panel Update-06 Kit 10638823 LabPro v4.11 Software Update Kit 10638825 LabPro v4.11 System Software 10638824 LabPro v4.11 Software Update Kit 10638826 LabPro v4.11 System Software Product Usage: LabPro Data Management System is a Microsoft Windows based software program and is intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST) data generated from MicroScan instruments or manually entered microbiology test results, for use by trained laboratory personnel. LabPro AlertEx is a functional subset of the LabPro Data Management System that analyzes MicroScan ID and AST data, or other predefined parameters, against a series of established rules/alerts and notifies the user of unusual and/or critical conditions, which may warrant further analysis or actions.
Product code: OUG Medical Device Data System
Reason for recall: 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.
Root cause tag: software
FDA root cause: Unknown/Undetermined by firm
Action: An Urgent Medical Device Recall Letter dated 2/11/2016 was sent to all customers who purchased the MicroScan LabPro Information Manager System, Version 1.0 to Version 4.41. Beckman Coulter is expanding the recall that was initiated in July 2015 regarding FA-25776 for the MicroScan LabPro Information Manager System. 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: 2,702 units total (1,032 units in US)
Distribution: Affected geographies: Bahamas, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, France, French Guiana, Germany, Ghana, Greece, Guadeloupe, Guatemala, India, Israel, Italy, Japan, Kazakhstan, Lithuania, Mexico, Morocco, Netherlands, Northern Mariana Islands, Panama, Paraguay, Peru, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, South Africa, Spain, Taiwan, Tunisia, Turkey, United States, Uruguay, Virgin Islands, Zimbabwe.
Product codes and lots: not applicable

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1269-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1269-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-06	2016-03-28

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)