Beckman Coulter, Inc. 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. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Beckman Coulter, Inc.
Lot Codes / Batch Numbers
Lot #583-21 and higher, UDI 10837461002611.
Products Sold
Lot #583-21 and higher, UDI 10837461002611.
Beckman Coulter, Inc. is recalling Beckman Coulter IRISpec CA/CB/CC control, Catalog #800-7211, containing 3 x 100 mL bottles each of C due to IRISpec CA failures for glucose.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
IRISpec CA failures for glucose.
Recommended Action
Per FDA guidance
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 The ranges superseded those listed in the IFU and the assay sheet C39721AA, and the letter emphasized to use only the specifications in the notification.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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026