Beckman Coulter, Inc.: Medical Device Recall in 2022 - (Recall #: Z-0984-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Beckman Coulter IRISpec CA/CB/CC control, Catalog #800-7211, containing 3 x 100 mL bottles each of CA Control, CB Control, and CC Control.

Product Classification:

Class III

Date Initiated: February 16, 2022

Date Posted: April 27, 2022

Recall Number: Z-0984-2022

Event ID: 89655

Reason for Recall:

IRISpec CA failures for glucose.

Status: Ongoing

Product Quantity: 12,306 kits

Code Information:

Lot #583-21 and higher, UDI 10837461002611.

Distribution Pattern:

Worldwide distribution - US Nationwide, including Puerto Rico and the countries of Brazil, Canada, Curacao, Guatemala, Mexico, Philippines, Singapore, and Taiwan.

Voluntary or Mandated:

Voluntary: Firm initiated