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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
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