COVID-19 antibody test assay recalled due to insufficient validation evidence
Beckman Coulter is recalling Access SARS-CoV-2 IgG test kits nationwide due to insufficient evidence in the FDA authorization submission. The test validation may be inadequate for accurate COVID-19 antibody detection.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm medical device (diagnostic test) where validation evidence was determined to be insufficient. While no illnesses or injuries have been reported, unreliable COVID-19 antibody test results pose significant potential harm to patients and public health.
Plain-English summary
Beckman Coulter Inc. is recalling Access SARS-CoV-2 IgG (1st IS) Assay kits, which are used to detect antibodies to the COVID-19 virus. The recalled components include the reagent pack (REF C74339), calibrators (REF C74340), and quality control materials (REF C74341).
The recall was initiated because the manufacturer's submission for FDA Emergency Use Authorization (EUA) contained insufficient evidence to support authorization for distribution of the device. The validation evidence provided was determined to be inadequate.
A total of 303 kits were distributed in the United States across 17 states and Puerto Rico, including Arizona, California, Georgia, Illinois, Iowa, Kentucky, Michigan, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Tennessee, Texas, Virginia, and Washington. An additional 964 kits were distributed outside the U.S.
Healthcare facilities and laboratories that received these kits should discontinue use and contact Beckman Coulter with questions regarding the recall.
The recalled product
- Product
- Access SARS CoV-2 IgG (1st IS) Assay: Access Immunoassay Systems REAGENT PACK, REF C74339 Access SARS-CoV-2 IgG (1st IS) Calibrators, REF C74340 Access SARS-CoV-2 (1st IS) Quality Control (QC), REF C74341
- Manufacturer
- Beckman Coulter Inc.
- Hazard
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 (8)
- Part Number: C74340 UDI Codes: (01)15099590746926(17)210930(11)210402(10)124467
- (01)15099590746926(17)211231(11)210703(10)124758
- Lot Numbers: 124467
- 124758
- Part Number: C74341 UDI Codes: (01)15099590746933(17)210930(11)210402(10)124468
- (01)15099590746933(17)211130(11)210602(10)124708
- Lot Numbers: 124468
- 124708
Distribution
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