The Recall Desk
HighFDA (Devices)·Z-0843-2020·Announced 2020-01-29

Beckman Coulter Recalls iChem VELOCITY Urine Chemistry Analyzers

Beckman Coulter is recalling iChem VELOCITY Urine Chemistry Analyzers because a software issue may prevent specific gravity flags, potentially leading to erroneous test results.

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 medical device defect that may result in erroneous diagnostic results (Specific Gravity). Per the rubric, this is classified as High (Score 3) because it is a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Beckman Coulter Inc. is recalling 4,314 units of the iChem VELOCITY Urine Chemistry Analyzer. The recall covers units distributed worldwide, including the United States (nationwide) and Puerto Rico, as well as numerous international locations.

The recall is due to an issue affecting the Specific Gravity chemistry settings. This defect prevents the trigger of a chemistry system flag (S3), which may result in erroneous Specific Gravity (SG) results. The source text does not report any illnesses or injuries associated with this defect.

Healthcare facilities and users should check their device serial numbers and software versions against the list provided in the official recall notice to determine if their units are affected. Users should contact Beckman Coulter for instructions on how to resolve the issue.

The recalled product

Product
iChem VELOCITY Urine Chemistry Analyzer
Manufacturer
Beckman Coulter Inc.
Category
Medical Device — Urine Chemistry Analyzer
Hazard
Affected units
4,314

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Related recalls

Same manufacturer · Beckman Coulter Inc.

See all →

Same hazard · erroneous results

See all →