CLASS II ONGOING Device recall · Reported 5 Apr 2023 · FDA Enforcement Report

MicroVue C1-Inhibitor Plus EIA recalled by Quidel

Quidel is recalling MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor. The recall was initiated on 1 Feb 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: 30014613335580; Lot Number: 213783

Quantity recalled771 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1308-2023
FDA event ID: 91772
Recalling firm: Quidel, Athens, OH
Classification: Class II
Status: Ongoing
Recall initiated: 1 Feb 2023
FDA classified: 30 Mar 2023
Reported: 5 Apr 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

1 Feb 2023	Recall initiated by company
30 Mar 2023	Classified by FDA	+57 days
5 Apr 2023	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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

Where it was distributed

not yet available

Questions about this recall

Why was it 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 lots are affected?

UDI: 30014613335580; Lot Number: 213783

Where was it sold?

not yet available

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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