MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional… — Class II medical device recall Z-1308-2023
Ongoing recall by Quidel Corporation, reported 2023-04-05. Kits with affected microtiter plates have the potential to produce low OD values, causing the run to fail, per
| Recall number | Z-1308-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Quidel Corporation, Athens, OH, United States |
| Recall initiated | 2023-02-01 |
| Classified | 2023-03-30 |
| Reported by FDA | 2023-04-05 |
| Quantity | 771 units |
| UPC / GTIN / UDI-DI | 30014613335580 |
| Lot numbers | 213783 |
| Model numbers | 4634, A037 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1308-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.