---
title: "MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhi... — FDA record Z-1308-2023 | Is It on Recall"
description: "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"
url: https://isitonrecall.com/recall/fda-device-z-1308-2023-microvue-c1-inhibitor-plus-eia-for-measuring-the-amount-of-functional-c1-lnhibitor-protein-in-human/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein in human plasma or serum, ... — FDA record Z-1308-2023

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Feb 1, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **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**: 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.
- **Classification**: Class II
- **Recalling firm**: Quidel Corporation
- **Quantity**: 771 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-1308-2023

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1308-2023%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | UDI: 30014613335580; Lot Number: 213783 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

not yet available

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: Apr 5, 2023
- **Recall initiation date**: Feb 1, 2023
- **Center classification date**: Mar 30, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1308-2023%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Quidel Corporation records](https://isitonrecall.com/brand/quidel-corporation/)