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Recall Observatory FDA recall evidence

Device product

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

Z-1058-2022

April 17, 2022

Class II

Product summary

Firm
PROTERIXBIO
Event
Event 90107
Status
Terminated
Classification
Class II
Quantity
640 kits
Official record key
device-enforcement:Z-1058-2022

Official wording

Reason: 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).

Code information: Lots were not coded. All product will be recalled.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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).