Reported Apr 5, 2023 · Ongoing

MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein in human plasma or serum,…

Quidel Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Quidel Corporation · 2005 E State St Ste 100 · Athens, OH · 45701-2125

Is this the product you have?

  • 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
Lot codes and dates
  • UDI30014613335580
  • Lot Number213783
Amount recalled
771 units

Why it was 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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:35 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.