Beckman Coulter MicroScan WalkAway-40 Plus Reconditioned Instruments Recalled
Beckman Coulter is recalling six reconditioned MicroScan WalkAway-40 Plus instruments due to a shortened reagent draw straw that may cause reagent dispensing failures and organism misidentification.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves potential organism misidentification and QC failure, which poses a risk of harm to patient care, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Beckman Coulter Inc. is recalling six reconditioned MicroScan WalkAway-40 Plus instruments. The recall is due to a manufacturing defect where the instruments were equipped with a shortened 30mL reagent draw straw.
This defect may result in reagents not dispensing correctly, which can lead to organism misidentification and/or Quality Control (QC) failure. The affected units are distributed in the United States (CO, FL, IL, IN, KY, ME, MI, MS, PA, Puerto Rico, TN, TX, UT, VA, and WA) and internationally (India, Indonesia, Italy, Japan, Philippines, Poland, Russia, South Korea, Taiwan, and Yemen).
The recalled instruments have Catalog Number B1018-340R and UDI Code 15099590684112. Affected serial numbers include 34020035, 34020224, 34030054, 3407179, 3407459, and 3407532. Users should contact Beckman Coulter for further instructions on how to proceed with the recall.
The recalled product
- Product
- MicroScan WalkAway-40 plus Reconditioned Instrument
- Manufacturer
- Beckman Coulter Inc.
- Affected units
- 6
Distribution
Part of a larger recall action
This product is one of 4 recalled by Beckman Coulter Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · Beckman Coulter Inc.
See all →- HighBeckman Coulter DxC 500 AU Analyzer Software Defect Recall
FDA (Devices) · 2026-08-26
- HighBeckman Coulter DxC 500i Analyzer Modules Recalled for Software Defect
FDA (Devices) · 2026-08-26
- SevereBeckman Coulter MicroScan Panel Update DVD Kits Recalled
FDA (Devices) · 2026-08-12
- High
- HighBeckman Coulter Access Total T4 Calibrator Recalled for Inaccurate Results
FDA (Devices) · 2026-04-29
Same hazard · mis identification
See all →- HighBar Code Reader Wands for GEM Premier Blood Analyzers Recalled Due to Misidentification Risk
FDA (Devices) · 2026-08-05
- HighDiagnostic Test Kits Recalled for False Vibrio Results With Certain Transport Medium
FDA (Devices) · 2024-08-14
- HighStryker INFINITY Resect Guide Recalled for Incorrect Color Coding
FDA (Devices) · 2022-07-06
- ModerateAlthaea Officinalis Homeopathic Pills Recall Due to Failed Identity Testing
FDA (Drugs) · 2021-10-06
- HighBeckman Coulter MicroScan WalkAway-96 plus Instruments Recalled for Reagent Dispensing Defect
FDA (Devices) · 2021-04-14