IRISpec CA/CB/CC URINE CHEMSITRY CONTROLSRecalls & reported problems
Beckman Coulter Ireland Inc. · IRISPEC CA/CB/CC URINE CHEMISTRY CONTROLS · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
3 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 3
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
3 FDA recall records name this device's identifier, 3 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Jul 16, 2024Open, Classified
Beckman Coulter has become aware of an increase in customer complaints for intermittent IRISpec CB negative glucose control failure, resulting in false positive control results when used in conjunction with iChemVELOCITY Urine Chemistry Strips (PNs 800-7204 and 800-7212) on the iChemVELOCITY Analyzer. This issue may delay the reporting of patient results, with a worst-case scenario of a delay in diagnosis or treatment of metabolic disorders, kidney function abnormalities, urinary tract infections, and liver function.
Z-0093-2025 · Root cause: Under Investigation by firm · FDA record ↗
- Nov 18, 2022Open, Classified
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
Z-0777-2023 · Root cause: Under Investigation by firm · FDA record ↗
- Feb 16, 2022Open, Classified
IRISpec CA failures for glucose.
Z-0984-2022 · Root cause: Under Investigation by firm · FDA record ↗
Other Urinalysis Controls (Assayed And Unassayed) devices
- Dipper Urinalysis Dipstick Control Level 1&2 Set 6x15mL 1440-01Quantimetrix Corporation · Urinalysis Controls (Assayed And Unassayed)1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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