Recall Z-0984-2022 ยท JJW Urinalysis Controls (Assayed And Unassayed)
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.
| Date | Feb 16, 2022 |
| Status | Open, Classified |
| Reason | IRISpec CA failures for glucose. |
| Root cause | Under Investigation by firm |
| Action | 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 The ranges superseded those listed in the IFU and the assay sheet C39721AA, and the letter emphasized to use only the specifications in the notification.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 se |
| Quantity | 12,306 kits |
| Distribution | Worldwide distribution - US Nationwide, including Puerto Rico and the countries of Brazil, Canada, Curacao, Guatemala, Mexico, Philippines, Singapore, and Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.