The Recall Desk
HighFDA (Devices)·Z-2257-2021·Announced 2021-08-18

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.

What this means for you

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.
Category
Medical Device — Diagnostic Test Reagent
Hazard
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

Distributed nationwide across the United States.

The notice also names 34 states specifically:

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.

See all 4 products in this recall →

Related recalls

Same manufacturer · Beckman Coulter Inc.

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Same hazard · false positive results

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