High FDA (Devices)·Z-0291-2014·Announced 2013-11-20

Beckman Coulter Recalls Access 2 Immunoassay System Due to Fuse Defect

Beckman Coulter is recalling the Access 2 Immunoassay System because the fuses may have the wrong amperage.

What this means for you

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 risk-of-harm product (electrical component defect) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Beckman Coulter Inc. is recalling the Access 2 Immunoassay System, Part Number 81600N. This in vitro diagnostic device is used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.

The recall was initiated because the manufacturer determined that the fuses in the system may be of the wrong amperage. A total of 8 units are affected, with 1 unit distributed in the United States and the remainder distributed in Colombia, Hong Kong, and Korea. The affected serial numbers are 508801, 508802, 508803, 508804, 508805, 508806, 508807, and 508810.

Users should contact Beckman Coulter for instructions on how to proceed with the recall.

The recalled product

Product: Access 2 Immunoassay System, Part Number: 81600N The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
Manufacturer: Beckman Coulter Inc.
Category: Medical Device — In Vitro Diagnostic
Hazard: electrical-defect

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 (8)

Serial Numbers: 508801
508802
508803
508804
508805
508806
508807
508810

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Beckman Coulter Inc.

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