FDA Medical Device Recalls (openFDA)
MESA BIOTECH, INC: Accula SARS-CoV-2 Test, REF: COV4100
- Recall number
- Z-1009-2022
- Recalling firm
- MESA BIOTECH, INC
- Product
- Accula SARS-CoV-2 Test, REF: COV4100
- Status
- Open, Classified
- Initiated
- 2022-04-06
- Posted
- not on file
- Terminated
- not on file
- Reason
- SARS-CoV-2 Test has an increased potential for false positive results, which may lead to a delay in correct diagnosis and treatment.
- Root cause
- Material/Component Contamination
- Action
- 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.
- Quantity
- 6162
- 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, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QJR
- Firm FEI
- 3013026082
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28