Severity
Moderate
ModerateClass IIOngoing
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.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
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 FDA Devices action (record #Z-1308-2023) was formally reported on April 5, 2023, with the manufacturer initiating the action on February 1, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. Quidel Corporation is listed as the recalling firm, operating out of Athens, OH. Federal records list the affected scope as 771 units.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: not yet available. Distribution scope 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, 3 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 - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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.
Affected scope
771 units
Related Recalls
6
3 from same agency
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.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Quidel Corporation. Units affected: 771 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 5, 2023. Severity: Moderate. Recall number: Z-1308-2023.
Where was the recalled product distributed? ▼
Distribution: not yet available.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1308-2023) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported April 5, 2023. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.