FDA Recalls Accula SARS-CoV-2 Test for False Positive Risk
Mesa Biotech is recalling approximately 6,162 units of the Accula SARS-CoV-2 Test due to an increased risk of false positive results, which could delay correct diagnosis and treatment.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification requires a minimum severity score of 4 per the rubric. Although no illnesses or injuries are reported, the potential for false positive test results in a diagnostic device represents a significant defect affecting diagnostic accuracy and patient care.
Plain-English summary
The Accula SARS-CoV-2 Test (REF: COV4100), manufactured by Mesa Biotech, Inc., is being recalled due to an increased potential for false positive results. Approximately 6,162 units were distributed across the United States in multiple states.
False positive test results occur when a test incorrectly indicates the presence of an infection that is not actually present. This increases the risk that patients could be incorrectly diagnosed and may experience delays in receiving the correct diagnosis and treatment.
The FDA classified this as a Class I recall.
The recalled product
- Product
- Accula SARS-CoV-2 Test, REF: COV4100
- Manufacturer
- MESA BIOTECH, INC
- Category
- Medical Device — Diagnostic Test
- Affected units
- 6,162
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
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