ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood Spot Collection Kit, no model num
Summary
The FDA issued a Class II for ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried by PROTERIXBIO. Reason: FDA review concluded that the test is insufficiently supported by clinical performance data, and results reported may not have been accurate (false po.
Details
Source
Device Recall
External ID
Z-1058-2022
Action Date
2022-05-18
Status
Terminated
Category
device
Product Description
ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood Spot Collection Kit, no model number
Lot/Code Info: Lots were not coded. All product will be recalled.
Quantity Affected: 640 kits
Reason for Recall
FDA review concluded that the test is insufficiently supported by clinical performance data, and results reported may not have been accurate (false positives or false negatives).
Distribution
Domestic distribution to CA CO FL IA MA MO NH NY OH OK TX VA
Type: Voluntary: Firm initiated
Recall Initiated: 2022-04-17
Company
Billerica, MA
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 140 device recalls issued in the same week, part of 403 device-related FDA actions this month.
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 (PROTERIXBIO) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does PROTERIXBIO have FDA actions?
This is the only FDA action we have on record for PROTERIXBIO in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1058-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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