BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For… recallZ-0777-2023 · Beckman Coulter, Inc. · initiated Nov 18, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Beckman Coulter, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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
FDA root cause category: Under Investigation by firm
What the company is doing
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."
Recall details
- Recall number
- Z-0777-2023
- Status
- Open, Classified
- Initiated by the company
- Nov 18, 2022
- Posted by the FDA
- Jan 3, 2023
- Recalling firm
- Beckman Coulter, Inc.
- Quantity
- 3657 units
- Product code
- JJW
- FDA submissions
- K072640
- Distribution
- US and Canada, Brazil, Korea, Mexico, Puerto Rico, Taiwan
Product description
BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only.
Code information (models, lots, serial numbers)
UDI/DI 10837461002611, Lot 565-21: 11-30-2022
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- IRISpec CA/CB/CC URINE CHEMSITRY CONTROLSBeckman Coulter Ireland Inc. · Urinalysis Controls (Assayed And Unassayed)3 recalls0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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