DeviceSignal · Recall classified
Beckman Coulter Inc.
FDA classified a device recall on 2026-08-05 · Class II · Z-2888-2026
EventRecall classified
Effective2026-08-05
ClassificationClass II
On 2026-08-05 the FDA classified a device recall from Beckman Coulter Inc. as Class II. Product: REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic installed on the…. Recall Z-2888-2026. The firm initiated it on 2026-06-26. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-2888-2026
- Classification
- Class II
- Classified on
- 2026-08-05
- Initiated on
- 2026-06-26
- Firm
- Beckman Coulter Inc.
- Reason
- Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."
- Product
- REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic installed on the following instruments: - B1018-280 MicroScan autoSCAN-4 Instrument - B1018-283 MicroScan WalkAway-40 plus Instrument - B1018-284 MicroScan WalkAway-96 plus Instrument - B1018-440 DxM-1040 MicroScan WalkAway Instrument - B1018-496 DxM-1096 MicroScan WalkAway Instrument
Every field above is as fda_device_enforcement published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_enforcement
- Source record
Z-2888-2026- Snapshot hash
ab5ada73bf212eb52a548aab0968a0fcee42807c61b0350e60e24bb6e2beed72- Source URL
- https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
- Observed
- 2026-09-08T16:22:09.483Z
- Transform
fda_device_enforcement_to_recall v1- Event rule
fda_device_recall_classified v1- Event key
c18babf1db4ba044682c7b16e5bcc4df118c3bf05a64af03a2a6fb7a321d0426- Signal type
device_recall.classified
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)