Beckman Coulter Recalls MicroScan WalkAway-96 plus Reconditioned Instruments
Beckman Coulter is recalling nine MicroScan WalkAway-96 plus Reconditioned 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 involves a medical device defect that may lead to organism misidentification, a risk-of-harm scenario where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Beckman Coulter Inc. is recalling nine MicroScan WalkAway-96 plus Reconditioned 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 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 specific units are identified by Catalog Number B1018-396R, UDI Code 15099590684129, and the following serial numbers: 3967245, 3967417, 3967493, 3967544, 3967634, 3967734, 3967914, 3928224, and 3968442.
Healthcare facilities and users should contact Beckman Coulter Inc. for instructions on how to proceed with the recall. The source text does not specify a particular action for end-users beyond the recall notification.
The recalled product
- Product
- MicroScan WalkAway-96 plus Reconditioned Instrument
- Manufacturer
- Beckman Coulter Inc.
- Affected units
- 9
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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