Beckman Coulter Recalls MicroScan WalkAway-40 plus Instruments
Beckman Coulter is recalling 16 MicroScan WalkAway-40 plus instruments because a shortened reagent straw may cause reagent dispensing failures, leading to organism misidentification or quality control failures.
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 involves a risk-of-harm product (medical device) where the defect may lead to organism misidentification, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Beckman Coulter Inc. is recalling 16 MicroScan WalkAway-40 plus instruments. The recall was initiated because the instruments were manufactured with a shortened 30mL reagent draw straw. This defect may result in reagents not dispensing correctly, which may lead to organism misidentification and/or Quality Control (QC) failure.
The affected instruments were 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 specific catalog number is B1018-283, UDI Code 1509959065866, and serial numbers range from 34010001 to 34010016.
Users of these instruments should contact Beckman Coulter Inc. for further instructions on how to address the defect.
The recalled product
- Product
- MicroScan WalkAway-40 plus Instrument
- Manufacturer
- Beckman Coulter Inc.
- Affected units
- 16
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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