CLASS II Device recall · Reported 21 Dec 2016 · FDA Enforcement Report
MicroScan LabPro Data Management System recalled by Beckman Coulter
Beckman Coulter is recalling MicroScan LabPro Data Management System. The recall was initiated on 25 Oct 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0768-2017
- FDA event ID
- 75576
- Recalling firm
- Beckman Coulter, Brea, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Oct 2016
- FDA classified
- 15 Dec 2016
- Reported
- 21 Dec 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 25 Oct 2016 | Recall initiated by company | |
| 15 Dec 2016 | Classified by FDA | +51 days |
| 21 Dec 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution -- United States and Mexico.
Questions about this recall
Is MicroScan LabPro Data Management System recalled?
Yes. Beckman Coulter recalled MicroScan LabPro Data Management System on 25 Oct 2016. The recall is Class II and its status is Terminated. Recall number Z-0768-2017.
Why was it recalled?
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.
Which lots are affected?
Software Version 4.42, Part No. 6000-0050, 6000-0051, 6000-0052, 6000-0053, 6000-0054, and 6000-0060.
Where was it sold?
Worldwide Distribution -- United States and Mexico.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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