Flow cytometers recalled over software that crashes during sample acquisition
Beckman Coulter is recalling 25 DxFLEX Flow Cytometers because a software error crashes the system during acquisition on a patient sample when running a customer defined protocol.
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: Scored 3 under the risk-of-harm criterion: a crash during patient sample acquisition delays results, and no injuries are reported.
Plain-English summary
The Beckman Coulter DxFLEX Flow Cytometer, catalog number C78500, is being recalled. The instrument is an in vitro diagnostic device for immunophenotyping across up to ten fluorescent detection channels using three lasers.
The recall follows a software error code that crashes during acquisition on a patient sample when running a customer defined acquisition protocol. The firm states this may lead to delayed patient results.
The recall covers 25 units carrying UDI-DI 15099590754013, distributed in California, Connecticut, Florida, Illinois, New York, Ohio, Oregon, Tennessee and Texas, and internationally. The FDA has classified the action as Class II.
The enforcement record reports no injuries. Laboratories operating an affected instrument should follow Beckman Coulter's instructions.
The recalled product
- Product
- DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping up to ten fluorescent detection channels using three lasers (488 nm, 638 nm and 405 nm) and two light…
- Manufacturer
- Beckman Coulter Inc.
- Affected units
- 25
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)
- Catalog Number: C78500 UDI-DI code: 15099590754013 Serial Numbers: BH44060
- BJ09004
- BJ14015
- BJ09010
- BJ13012
- BJ14014
- BJ13011
- BJ14017
- BJ13013
- BJ09003
- BJ09008
- BJ09009
- BH39057
- BH44059
- BJ14016
- BJ05002
- BJ17020
- BJ17021
- BH26031
- BJ19024
Distribution
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