Beckman Coulter SARS-CoV-2 Antigen QC Reagent Recalled Due to False Positive Risk
Beckman Coulter is recalling ACCESS SARS-CoV-2 Antigen QC reagent due to false positive test results that could lead to incorrect diagnoses. The Class II recall affects 544 units distributed nationally and internationally.
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: Class II diagnostic reagent capable of producing false positive SARS-CoV-2 test results that could lead to incorrect diagnosis. No illnesses or injuries have been reported. The recall qualifies as High due to documented risk of diagnostic error without reported clinical harm.
Plain-English summary
Beckman Coulter Inc. is recalling ACCESS SARS-CoV-2 Antigen QC, Reference C68670. The product is an in vitro diagnostic reagent supplied with three 6.0 mL vials of QC1, three 6.0 mL vials of QC2, and one QC value card per unit. All lot numbers are affected.
The SARS-CoV-2 Antigen Assay utilizing this quality control reagent may generate false positive results, which could result in incorrect diagnosis.
This Class II medical device recall affects 544 units. Distribution includes United States (Alabama, Alaska, Arizona, Arkansas, California, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Mississippi, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia, West Virginia, and Wisconsin) as well as international distribution to New Zealand and Libya.
The recalled product
- Product
- ACCESS SARS-CoV-2 ANTIGEN QC, REF: C68670, CONTENTS: 3 X 6.0 mL QC1, 3 x 6.0 mL QC2, 1 QC VALUE CARD, IVD, Rx Only, UDI: (01)15099590742737;
- Manufacturer
- Beckman Coulter Inc.
- Affected units
- 544
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 (1)
- All Lots
Distribution
Part of a larger recall action
This product is one of 4 recalled by Beckman Coulter Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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