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U.S. Department of Health and Human Services

Class 2 Device Recall ProterixBio SARSCoV2 (RBD) IgG Antibody Test

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  Class 2 Device Recall ProterixBio SARSCoV2 (RBD) IgG Antibody Test see related information
Date Initiated by Firm April 17, 2022
Create Date May 11, 2022
Recall Status1 Terminated 3 on January 23, 2024
Recall Number Z-1058-2022
Recall Event ID 90107
Product Classification Reagent, coronavirus serological - Product Code QKO
Product ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood Spot Collection Kit, no model number
Code Information Lots were not coded. All product will be recalled.
Recalling Firm/
Manufacturer		 PROTERIXBIO
1 Fortune Dr
Billerica MA 01821-3923
Manufacturer 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).
FDA Determined
Cause 2		 Other
Action On April 17, 2022, the firm notified affected physicians who had ordered tests and received results since September 2020 via email. Customers were informed that the prior test results may not have been accurate. In addition, customers were instructed to check their stock and destroy any remaining Dried Blood Spot Collection Kits (ProterixBio SARS-CoV-2 RBD Antibody Test sampling kits). Customers should note the number of kits destroyed in their response to the recalling firm. For questions and clarifications regarding this notification please call ProterixBio at 978-901-6649 or email support@proterixbio.com. Business hours are 8 am to 4:30 pm, Eastern Time.
Quantity in Commerce 640 kits
Distribution Domestic distribution to CA CO FL IA MA MO NH NY OH OK TX VA
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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