Z-1009-2022 Class I Ongoing
FDA device recall Z-1009-2022 was initiated by MESA BIOTECH, INC on April 6, 2022 and is designated Class I. 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. The recall status is ongoing. Affected quantity: 6162.
Recall Details
- Product Type
- Devices
- Report Date
- May 18, 2022
- Initiation Date
- April 6, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6162
Product Description
Accula SARS-CoV-2 Test, REF: COV4100
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.
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.
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