FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc.: 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.
- Recall number
- Z-0768-2017
- Recalling firm
- Beckman Coulter 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.
- Status
- Terminated
- Initiated
- 2016-10-25
- Posted
- 2016-12-15
- Terminated
- 2017-05-01
- Reason
- 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
- 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
- 131 units total (130 units in US)
- Distribution
- Worldwide Distribution -- United States and Mexico.
- Lot, serial or model codes
- Software Version 4.42, Part No. 6000-0050, 6000-0051, 6000-0052, 6000-0053, 6000-0054, and 6000-0060.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OUG
- Firm FEI
- 2050012
- Firm city
- Brea
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28