MESA BIOTECH, INC Accula SARS-CoV-2 Test, REF: COV4100 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Accula SARS-CoV-2 Test, REF: COV4100
Brand
MESA BIOTECH, INC
Lot Codes / Batch Numbers
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
Products Sold
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
MESA BIOTECH, INC is recalling Accula SARS-CoV-2 Test, REF: COV4100 due to SARS-CoV-2 Test has an increased potential for false positive results, which may lead to a delay in correct diagnosis and treatment.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
SARS-CoV-2 Test has an increased potential for false positive results, which may lead to a delay in correct diagnosis and treatment.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026