MESA BIOTECH, INC: Medical Device Recall in 2022 - (Recall #: Z-1009-2022)

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:

Accula SARS-CoV-2 Test, REF: COV4100

Product Classification:

Class I

Date Initiated: April 6, 2022

Date Posted: May 18, 2022

Recall Number: Z-1009-2022

Event ID: 90013

Reason for Recall:

SARS-CoV-2 Test has an increased potential for false positive results, which may lead to a delay in correct diagnosis and treatment.

Status: Ongoing

Product Quantity: 6162

Code Information:

UDI/DI: B540COV41000; P22006-026, P22010-021, P22024-023, P22024-030, P22026-006, P22026-012, P22026-016 , P22010-001, P22010-030, P22024-026, P22024-032, P22026-007, P22026-013, P22026-017 , P22010-017, P22010-032, P22024-027, P22026-002, P22026-008, P22026-014, P22026-019 , P22010-019, P22024-021, P22024-028, P22026-004, P22026-009, P22026-015, P22032-011

Distribution Pattern:

US Nationwide distribution in the states of CA, TX, MA, NY, FL, NC, NJ, GA, CO, HI, PA, WA, NY, VA, MD, KY, WI, IL, PR, ND, MI, TN, AZ, UT.

Voluntary or Mandated:

Voluntary: Firm initiated