Z-0768-2017Class II

MicroScan LabPro Data Management System. Intended to manage both microbial identification (ID) and...

Name: Z-0768-2017 MicroScan LabPro Data Management System. Intended to manage both microbial identification (ID) and...
Creator: Beckman Coulter Inc.
Published: 2016-10-25
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2016-10-25 / Terminated / root cause: design

FDA source

Beckman Coulter Inc. began a recall of MicroScan LabPro Data Management System. Intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST) data... on 2016-10-25. FDA classified it as Class II and gives the reason as "Beckman Coulter has received and confirmed reports of an intermittent and unexpected behavior when loading new panels into a WalkAway instrument using LabPro Data Management System version 4.42. The issue could cause...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0768-2017
Classification: Class II
Status: Terminated
Initiated: 2016-10-25
Posted: 2016-12-15
Terminated: 2017-05-01
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: MicroScan LabPro Data Management System. 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.
Product code: OUG Medical Device Data System
Reason for recall: Beckman Coulter has received and confirmed reports of an intermittent and unexpected behavior when loading new panels into a WalkAway instrument using LabPro Data Management System version 4.42. The issue could cause workflow interruption with a potential of delaying reporting results due to the inability to begin processing new panels.
Root cause tag: design
FDA root cause: Device Design
Action: An Urgent Medical Device Recall letter dated 10/25/16 was sent to all their customers to inform them that Beckman Coulter has received and confirmed reports of an intermittent and unexpected behavior when loading new panels into a WalkAway instrument using LabPro Data Management System version 4.42. Customers are informed that the issue could cause WalkAway workflow interruption with a potential of delaying reporting results due to the inability to begin processing new panels. The letter informs the customers of the actions to be taken and the resolution for the product on recall. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with any questions regarding the notice are instructed to contact their Customer Support representative: http://www.beckmancoulter.com or call 1-800-677-7226, option 1 in the United States.
Quantity in commerce: 131 units total (130 units in US)
Distribution: Worldwide Distribution -- United States and Mexico.
Product codes and lots: Software Version 4.42, Part No. 6000-0050, 6000-0051, 6000-0052, 6000-0053, 6000-0054, and 6000-0060.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0768-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0768-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-21	2016-12-15

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)