Z-0984-2022 Class III Ongoing
FDA device recall Z-0984-2022 was initiated by Beckman Coulter, Inc. on Feb 16, 2022 and is designated Class III. Reason for recall: IRISpec CA failures for glucose. The recall status is ongoing. Affected quantity: 12,306 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 27, 2022
- Initiation Date
- Feb 16, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,306 kits
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.
Reason for Recall
IRISpec CA failures for glucose.
Distribution Pattern
Worldwide distribution - US Nationwide, including Puerto Rico and the countries of Brazil, Canada, Curacao, Guatemala, Mexico, Philippines, Singapore, and Taiwan.
Code Information
Lot #583-21 and higher, UDI 10837461002611.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0984-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026