The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- Product Name: Accula SARS-CoV-2 Test
- Product Codes: QJR
- Lot Numbers: See recall database entry
- Manufactured Dates: December 30, 2021 to January 1, 2022; January 15, 2022 to January 23, 2022
- Distribution Dates: January 19, 2022 to February 8, 2022
- Devices Recalled in the U.S.: 6,177
- Date Initiated by Firm: April 6, 2022
The Accula SARS-CoV-2 Test is a polymerase chain reaction (PCR) test intended to detect the presence of SARS-CoV-2, the virus that causes COVID-19, based on a nasal swab sample from patients. The sample is collected by healthcare providers or by people swabbing themselves under the guidance of a healthcare provider. This test is authorized for use in point of care (POC) settings. The sample is processed using special PCR laboratory equipment.
Reason for Recall
Mesa Biotech is recalling the Accula SARS-CoV-2 Test because certain lots of the test have an increased risk of giving false positive results due to contamination at the manufacturing facility.
Although there have been no reports of injuries, adverse health consequences, or death associated with the use of these affected products, false positive results could lead to further exposure of uninfected individuals to SARS-CoV-2 virus.
Who May be Affected
- Distributors of the Mesa Biotech, Inc., Accula SARS-CoV-2 Test
- Healthcare providers at the point of care who use the Accula SARS-CoV-2 Test
- People who were tested for COVID-19 using the Accula SARS-CoV-2 Test
What to Do
On April 6, 2022, Mesa Biotech issued a Product Recall letter to all customers who received the identified lots of Accula SARS-CoV-2 test kits. Customers were instructed to:
- Stop using test kits from the identified lots
- Discard or return remaining inventory from the identified lots
Customers were also asked to return a customer reply form acknowledging receipt and understanding of the issue.
Customers with questions or concerns about this recall may contact Mesa Biotech at 1-858-800-4929, or 1-800-955-6288, option 2.
- Medical Device Recall Database Entry
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.