PROTERIXBIO: Medical Device Recall in 2022 - (Recall #: Z-1058-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 17, 2022

Date Posted: May 18, 2022

Recall Number: Z-1058-2022

Event ID: 90107

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).

Status: Terminated

Product Quantity: 640 kits

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

Voluntary or Mandated:

Voluntary: Firm initiated