FDA Devices recall · Reported October 23, 2024
Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro diagnostic device.
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 wh…
Beckman Coulter, Inc. recalled Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 an… - a low-severity action.
Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 an… was recalled by Beckman Coulter, Inc. in October 23, 2024. Reason: Beckman Coulter has become aware of an increase in customer complaints for intermittent IRISpec CB negative g…. Check the official notice for the remedy. Verify recall #Z-0093-2025 with the FDA Devices before acting.
The recall
Beckman Coulter, Inc. issued this low-severity FDA Devices recall-Beckman Coulter has become aware of an increase in customer complaints for intermittent IRISpec CB negative g….
- Low
- severity level
- 6K units
- affected scope
- Class III
- classification
- October 23, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0093-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro diagnostic device.
Reason for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Ongoing |
| Recall number | Z-0093-2025 |
| Date reported | October 23, 2024 |
| Date initiated | July 16, 2024 |
| Recalling firm | Beckman Coulter, Inc. |
| Firm location | Miami, FL |
| Affected scope | 5589 units |
| Distribution | worldwide |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0093-2025) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Low), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026