Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 - Product Recalled by Beckman Coulter Inc. Due to The Quality Control (QC) card has a label...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Beckman Coulter Inc. directly.
Affected Products
ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 - Product Usage: use on the Access Family of Immunoassay Systems only.
Quantity: 276 units
Why Was This Recalled?
The Quality Control (QC) card has a label error for the standard deviation (SD) values for one out of the two levels of QC.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Beckman Coulter Inc.
Beckman Coulter Inc. has 241 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report