FDA Devices recall · Reported April 5, 2023
MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein in human plasma or serum, Catalog Number A037, Containing Coated Strips, REF: 4634, with an ID number of 2200 or above
Kits with affected microtiter plates have the potential to produce low OD values, causing the run to fail, per the Validation requirements of the Package Insert.
Quidel Corporation recalled MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protei… - a moderate-severity action.
MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protei… was recalled by Quidel Corporation in April 5, 2023. Reason: Kits with affected microtiter plates have the potential to produce low OD values, causing the run to fail, pe…. Check the official notice for the remedy. Verify recall #Z-1308-2023 with the FDA Devices before acting.
The recall
Quidel Corporation issued this moderate-severity FDA Devices recall-Kits with affected microtiter plates have the potential to produce low OD values, causing the run to fail, pe….
- Moderate
- severity level
- 771 units
- affected scope
- Class II
- classification
- April 5, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1308-2023 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 moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein in human plasma or serum, Catalog Number A037, Containing Coated Strips, REF: 4634, with an ID number of 2200 or above
Reason for recall
Kits with affected microtiter plates have the potential to produce low OD values, causing the run to fail, per the Validation requirements of the Package Insert.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1308-2023 |
| Date reported | April 5, 2023 |
| Date initiated | February 1, 2023 |
| Recalling firm | Quidel Corporation |
| Firm location | Athens, OH |
| Affected scope | 771 units |
| Distribution | not yet available |
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-1308-2023) 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
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Similar severity · nearest report date
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Similar Medical Devices · nearest report date
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Methodology · Corrections · Archive as of August 2026