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.
- Company
- Beckman Coulter, Inc.
- Recall Initiated
- February 16, 2022
- Recall Number
- Z-0984-2022
- Quantity
- 12,306 kits
- Firm Location
- Miami, FL
Reason for Recall
IRISpec CA failures for glucose.
Distribution
Worldwide distribution - US Nationwide, including Puerto Rico and the countries of Brazil, Canada, Curacao, Guatemala, Mexico, Philippines, Singapore, and Taiwan.
Lot / Code Info
Lot #583-21 and higher, UDI 10837461002611.
Root Cause
Under Investigation by firm
Action Taken
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 The ranges superseded those listed in the IFU and the assay sheet C39721AA, and the letter emphasized to use only the specifications in the notification.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.