MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein in human plasma or serum, Cat
Summary
The FDA issued a Class II for MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibit by Quidel Corporation. 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 Pack.
Details
Source
Device Recall
External ID
Z-1308-2023
Action Date
2023-04-05
Status
Ongoing
Category
device
Product Description
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/Code Info: UDI: 30014613335580; Lot Number: 213783
Quantity Affected: 771 units
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.
Distribution
not yet available
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-01
Company
Athens, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 119 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Quidel Corporation has 14 FDA actions in our database, including 8 recalls and 6 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Quidel Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Quidel Corporation have FDA actions?
Quidel Corporation has 14 FDA actions in our database, including 8 recalls and 6 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1308-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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