Beckman Coulter Power Express Sample Processing System Recall for Biohazard Risk
Beckman Coulter is recalling 291 Power Express Sample Processing System units due to a software design problem that causes sample splashing and potential biohazard exposure.
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 the hazard involves potential exposure to biohazard (infection risk) without reported illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Beckman Coulter Inc. is recalling 291 units of the Power Express Sample Processing System AU5800XL connection unit (catalog #B36351) and Power Express Dynamic Inlet (catalog B36352). The recall affects units installed before May 20, 2019, with specific serial numbers listed in the agency record.
The recall is due to a software design problem that causes excess speed and vibrations in the unload arm movement. This mechanical issue results in sample splashing, which creates a potential exposure to biohazard. The affected units were distributed to 23 U.S. states and 24 foreign countries.
Healthcare facilities and laboratories should identify affected units by checking the serial numbers against the list provided by the FDA. Users should contact Beckman Coulter for instructions on how to proceed with the recall and remediation of the software defect.
The recalled product
- Product
- Beckman Coulter Power Express Sample Processing System AU5800XL connection unit, catalog #B36351; and Power Express Dynamic Inlet, catalog B36352.
- Manufacturer
- Beckman Coulter Inc.
- Affected units
- 291
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- PW211501005
- PW211501006
- PW211501007
- PW211501008
- PW211501013
- PW211505001
- PW211508003
- PW211509002
- PW211510001
- PW211510002
- PW211511001
- PW211511002
- PW211511003
- PW211511005
- PW211512001
- PW211601001
- PW211601002
- PW211602002
- PW211602003
- PW211602004
Distribution
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