—#197183

Product

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

FDA product code: JJW — Urinalysis Controls (Assayed And Unassayed)
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K072640
Affected lot / code info: UDI/DI 10837461002611, Lot 565-21: 11-30-2022

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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."

Recalling firm

Firm: Beckman Coulter, Inc.
Address: 11800 Sw 147th Ave, Miami, Florida 33196-2500

Distribution

Distribution pattern: US and Canada, Brazil, Korea, Mexico, Puerto Rico, Taiwan

Timeline

Recall initiated: 2022-11-18
Posted by FDA: 2023-01-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #197183. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.