Lower riskMedical device recall · FDA · Published February 1, 2023
Quidel MicroVue C1-Inhibitor Plus EIA Recall: Low OD Values May Cause Failed Tests
Quidel recalls MicroVue C1-Inhibitor Plus EIA kits with specific lot numbers for potential low OD values causing test failures. Affected kits may produce inaccurate results.
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.
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Contact the company
📍Recalling firmQuidel Corporation2005 E State St Ste 100 · Athens, OH 45701-2125
✎ GovInfoNow plain-language explainer
Quidel is recalling certain MicroVue C1-Inhibitor Plus EIA kits that may produce low optical density (OD) values, causing test runs to fail. This could lead to inaccurate results in measuring functional C1-inhibitor protein levels in blood tests. Read more at govinfonow.com/recall/58983-quidel-microvue-c1-inhibitor-plus-eia-recall-low-od-values.
“Quidel MicroVue C1-Inhibitor Plus EIA Recall: Low OD Values May Cause Failed Tests.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58983-quidel-microvue-c1-inhibitor-plus-eia-recall-low-od-values. Based on FDA recall #Z-1308-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1308-2023%22&limit=1).
Quidel Corporation voluntarily recalled MicroVue C1-Inhibitor Plus EIA kits due to potential low OD values causing test failures, the FDA said on Feb. 1, 2023. The recall involves 771 units distributed before availability.
How to tell if you have it
Brand: Quidel
Product: MicroVue C1-Inhibitor Plus EIA
Catalog Number: A037
REF: 4634
ID number: 2200 or above
UDI: 30014613335580
Lot Number: 213783
The hazard
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.
Context
GovInfoNow's records show Quidel Corporation has 10 other recalls on record since June 22, 2017. Other recent recalls include the Quidel QuickVue Strep A Test Recall (April 6, 2026), the Quidel QuickVue Strep A Dipstick Test Recall (June 17, 2025), and the Quidel InflammaDry MMP-9 Test Recall (March 5, 2024). Other recent recalls of similar products include the Siemens Healthcare Syva EMIT 2000 Quinidine Assay Recall (July 13, 2026), the LH One Step Ovulation Test Device Recall (Nov. 22, 2025), and the Beckman Coulter Emit 2000 Quinidine Assay Recall (July 13, 2026).
How to tell if you have this one
Check the lot number on the kit label; affected kits have lot number 213783 or higher. The product includes a unique identifier (UDI) starting with 30014613335580.
Brand
Quidel
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Lot Number
Look for the lot number on the kit label; affected kits have a lot number of 213783 or higher.
How this recall unfolded
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1308-2023 (February 1, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1308-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.