Summary
The FDA issued a Class I for Accula SARS-CoV-2 Test, REF: COV4100 by MESA BIOTECH, INC. Reason: SARS-CoV-2 Test has an increased potential for false positive results, which may lead to a delay in correct diagnosis and treatment..
Details
Source
Device Recall
External ID
Z-1009-2022
Action Date
2022-05-18
Status
Ongoing
Category
device
Product Description
Accula SARS-CoV-2 Test, REF: COV4100
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
Quantity Affected: 6162
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-04-06
Company
San Diego, CA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 140 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (MESA BIOTECH, INC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does MESA BIOTECH, INC have FDA actions?
This is the only FDA action we have on record for MESA BIOTECH, INC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1009-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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