Recall Z-0777-2023 ยท JJW Urinalysis Controls (Assayed And Unassayed)
Beckman Coulter, Inc.
BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only.
| Date | Jan 3, 2023 (initiated Nov 18, 2022) |
| Status | Open, Classified |
| Reason | Beckman Coulter has become aware of an increase in customer complaints generated for intermittent IRISpec CB glucose control false positive results when used in conjunction with iChemVelocity Urine Chemistry Strips PN 800-7212 |
| Root cause | Under Investigation by firm |
| Action | The firm issued a MEDICAL DEVICE RECALL notice to its consignees on 11/18/2022 by mail and email. The notice explained the problem and requested the following actions be taken: "If IRISpec CB controls pass (QC results are within QC acceptance criteria): Continue to process patient samples per IFU (P/N 301-7146BE) If IRISpec CB controls fail (QC results are outside QC acceptance criteria): Refer to Addendum A below for troubleshooting No retrospective review of QC or patient sample results is necessary." "Please share this information with your laboratory staff and retain this notification |
| Quantity | 3657 units |
| Distribution | US and Canada, Brazil, Korea, Mexico, Puerto Rico, Taiwan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072640 | IRISPEC,CA/CB/CC Iris Diagnostics, Dec 21, 2007 |