Lower riskMedical device recall · FDA · Published February 16, 2022
Beckman Coulter IRISpec CA Control Recall: Glucose Measurement Failures
Beckman Coulter recalls IRISpec CA/CB/CC control kits with potential glucose measurement failures. Affected units include specific catalog numbers and lots. Consumers should contact the manufacturer for details.
“Beckman Coulter IRISpec CA Control Recall: Glucose Measurement Failures.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61138-beckman-coulter-irispec-ca-control-recall-glucose-measurement-failures. Based on FDA recall #Z-0984-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0984-2022%22&limit=1).
Beckman Coulter, Inc. recalled Beckman Coulter IRISpec CA/CB/CC control kits containing CA Control due to potential glucose testing failures, according to the FDA on Feb. 16, 2022.
How to tell if you have it
Brand: Beckman Coulter
Product: Beckman Coulter IRISpec CA/CB/CC control
Catalog #: 800-7211
Lot codes: #583-21 and higher
UDI: 10837461002611
Quantity: 12,306 kits
The hazard
The recall addresses IRISpec CA failures for glucose. The FDA classified the recall as Class III.
Context
GovInfoNow's records show Beckman Coulter, Inc. has 133 other recalls on record since June 20, 2017. Other recent recalls of similar products include Siemens Atellica CH A1c_E Test Recall (June 8, 2026), Beckman Coulter Emit 2000 Quinidine Assay Recall (July 13, 2026), and FreeStyle Libre 14 Day Sensor Recall (Nov. 24, 2025).
How to tell if you have this one
Check for catalog number 800-7211 and lot numbers 583-21 or higher on the control kit packaging. The kit contains three 100 mL bottles of CA Control, CB Control, and CC Control.
Brand
Beckman Coulter
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Contact Manufacturer
Reach out to Beckman Coulter for specific instructions on how to handle the affected control kits.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide, including Puerto Rico and the countries of Brazil, Canada, Curacao, Guatemala, Mexico, Philippines, Singapore, and Taiwan.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0984-2022 (February 16, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0984-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.