Accula SARS-CoV-2 Test, REF: COV4100

Company

Mesa Biotech, Inc

Recall Initiated

April 6, 2022

Recall Number

Z-1009-2022

Quantity

6162

Firm Location

San Diego, CA

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

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.

Lot / Code Info

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

Root Cause

Material/Component Contamination

Action Taken

On 04/06/22, recall notices were mailed to customers. Customers were informed that the reliability of negative test results is not affected. Customers with affected devices were asked to do the following: 1. Discontinue use of any affected product immediately 2. All affected product must either be returned or discarded. Replacement product will be provided for all returned and discarded product upon receipt of Customer/Distributor Response Sheet. 3. Notify all impacted users in your facility. If you have shipped any of these lots outside of your facility, you must notify those customers or facilities of this voluntary recall. 4. Complete and return the Customer/Distributor Response Sheet, which can be emailed to USSD2.customercare@thermofisher.com Customers with questions are encouraged to contact the recalling firm at: +1-858-800-4929, or 1-800-955-6288, option 2.