Beckman Coulter, Inc.: Medical Device Recall in 2023 - (Recall #: Z-0777-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only.

Product Classification:

Class II

Date Initiated: November 18, 2022

Date Posted: January 11, 2023

Recall Number: Z-0777-2023

Event ID: 91175

Reason for Recall:

Beckman Coulter has become aware of an increase in customer complaints generated for intermittent IRISpec CB glucose control false positive results when used in conjunction with iChemVelocity Urine Chemistry Strips PN 800-7212

Status: Ongoing

Product Quantity: 3657 units

Code Information:

UDI/DI 10837461002611, Lot 565-21: 11-30-2022

Distribution Pattern:

US and Canada, Brazil, Korea, Mexico, Puerto Rico, Taiwan

Voluntary or Mandated:

Voluntary: Firm initiated