Beckman Coulter IRISpec CA/CB/CC control, Catalog… recallZ-0984-2022 · Beckman Coulter, Inc. · initiated Feb 16, 2022

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Beckman Coulter, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

IRISpec CA failures for glucose.

FDA root cause category: Under Investigation by firm

What the company is doing

The recall letter was issued via email on 2/17/2022 and by first class mail on 2/18/2022 for U.S. consignees. The letter explained the issue, the impact of the issue, and the actions to be taken by the consignee. The consignee was to update the quality control QC ranges for glucose as instructed in the letter. The ranges superseded those listed in the IFU and the assay sheet C39721AA, and the letter emphasized to use only the specifications in the notification. As an interim action, a lower limit on the glucose control range was being implemented via the notification. The letter was to serve as a labeling update for the issue until further notice. The information was to be shared with the consignee's laboratory staff and retained as part of the laboratory Quality System documentation. If the product has been forwarded to another laboratory, the consignee is to provide them a copy of the letter. The consignee was requested to respond to the notification electronically or manually within 10 days. A response form was enclosed for completion and return. Also enclosed was an addendum which provided instructions for updating the QC ranges for glucose in the analyzer. OUS consignees were notified via email and first class USPS beginning 2/16/2022.

Recall details

Recall number: Z-0984-2022
Status: Open, Classified
Initiated by the company: Feb 16, 2022
Recalling firm: Beckman Coulter, Inc.
Quantity: 12,306 kits
Product code: JJW
Distribution: Worldwide distribution - US Nationwide, including Puerto Rico and the countries of Brazil, Canada, Curacao, Guatemala, Mexico, Philippines, Singapore, and Taiwan.

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.

Code information (models, lots, serial numbers)

Lot #583-21 and higher, UDI 10837461002611.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

IRISpec CA/CB/CC URINE CHEMSITRY CONTROLS
Beckman Coulter Ireland Inc. · Urinalysis Controls (Assayed And Unassayed)
3 recalls0 reports

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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