Beckman Coulter Recalls UniCel Dxl 600 Access Immunoassay Systems
Beckman Coulter is recalling 432 UniCel Dxl 600 Access Immunoassay Systems due to confirmed field modifications to probe assemblies.
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, which corresponds to a High severity score under the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Beckman Coulter Inc. is recalling 432 units of the UniCel Dxl 600 Access Immunoassay System, including part numbers A30260, A71460, and A71461. The affected devices are in vitro diagnostic instruments used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations in human body fluids. The recall covers serial numbers 900000 through 900491.
The recall was initiated because Beckman Coulter confirmed that the UniCel Dxl and DxC Access Immunoassay Systems had field modifications to the aspirate and dispense probe assemblies. This recall is classified as Class II by the U.S. Food and Drug Administration.
The affected products were distributed worldwide, including nationwide in the United States and internationally to numerous countries. Users of these devices should contact Beckman Coulter for further instructions regarding the field modifications.
The recalled product
- Product
- UniCel Dxl 600 Access Immunoassay System, Part Numbers: A30260, A71460, and A71461. The UniCel DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human…
- Manufacturer
- Beckman Coulter Inc.
- Hazard
- Affected units
- 432
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 (1)
- Serial Numbers: 900000 through 900491.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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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