Beckman Coulter, Inc. BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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

Recommended Action

Per FDA guidance

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 as part of your laboratory Quality System documentation. If you have forwarded any of the affected product listed above to another laboratory, please provide them a copy of this letter."

Distribution

As reported by FDA

PR