Beckman Coulter MicroScan WalkAway-96 plus Instruments Recalled for Reagent Dispensing Defect
Beckman Coulter is recalling 12 MicroScan WalkAway-96 plus instruments because a shortened reagent straw may prevent proper dispensing, leading to misidentification or quality control failure.
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 and involves a risk of organism misidentification, which poses a significant 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 12 MicroScan WalkAway-96 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 can lead to organism misidentification and/or Quality Control (QC) failure.
The affected units are identified by Catalog Number B1018-284 and UDI Code 15099590658687. The specific serial numbers involved are 39610001 through 39610012. The FDA has classified this recall as Class II.
The instruments were distributed in the United States to Colorado, Florida, Illinois, Indiana, Kentucky, Maine, Michigan, Mississippi, Pennsylvania, Puerto Rico, Tennessee, Texas, Utah, Virginia, and Washington. They were also distributed internationally to India, Indonesia, Italy, Japan, the Philippines, Poland, Russia, South Korea, Taiwan, and Yemen. Users should contact Beckman Coulter for instructions on how to address the defect.
The recalled product
- Product
- MicroScan WalkAway-96 plus Instrument
- Manufacturer
- Beckman Coulter Inc.
- Affected units
- 12
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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