Beckman Coulter Inc.: Medical Device Recall in 2018 - (Recall #: Z-1894-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

iChem VELOCITY Automated Urine Chemistry System, Catalog #700-7176-001 and iChem VELOCITY Automated Urine Chemistry System Computerless, Catalog #700-7177-001. The iChemVELOCITY automated urine chemistry system is an in-vitro diagnostic device used to automate the urine chemistry analysis profile using iChemVELOCITY Urine Chemistry Strips. The iChemVELOCITY can be used as a stand-alone system, as well as in a iQ200 Series system, a configuration given the proprietary name iRICELL as it is designed to be hardware and software compatible with iQ200 Series systems.

Product Classification:

Class II

Date Initiated: March 29, 2018

Date Posted: May 30, 2018

Recall Number: Z-1894-2018

Event ID: 79895

Reason for Recall:

The Strip Provider Modules (SPM) on some of the instruments had not been inspected during manufacture for correct seal placement and integrity.

Status: Terminated

Product Quantity: 6 devices

Code Information:

Catalog 700-7176-001 - Serial numbers V04494 and CV04015; Catalog 700-7177-001 - Serial numbers CV04012, CV04013, CV04014, and CV04017.

Distribution Pattern:

US Distribution to states of: AL, IA, GA, and FL.

Voluntary or Mandated:

Voluntary: Firm initiated