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Terminated

ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood Spot Collection Kit, no model number

FDA Recall Z-1058-2022 · Posted None

Recalling FirmPROTERIXBIO
Recall StatusTerminated
Product CodeQKO
Date Initiated2022-04-17
Date Terminated2024-01-23
Product Quantity640 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).

Firm 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 [email protected]. Business hours are 8 am to 4:30 pm, Eastern Time.

Root Cause

Other

Distribution Pattern

Domestic distribution to CA CO FL IA MA MO NH NY OH OK TX VA

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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