Recall Z-1905-2021— Beckman Coulter Inc.

Name: FDA recall Z-1905-2021
Creator: U.S. Food and Drug Administration
Published: 2021-05-07

Class II · Terminated

Class II FDA medical device recall by Beckman Coulter Inc., initiated 2021-05-07, terminated 2023-03-27. FDA's recall record names no specific 510(k) clearance for this event. Product: Access SARS CoV-2 lgG II Reagent, REF: C69057, IVD CE UDI: (01)15099590742744. Reason: SARS-CoV-2 lgG II numerical results may potentially be multiplied by a factor of 1000 on systems running with assay protocol file (APF) and access assay file (AAF) versions resulting in falsely elevated numerical values..

Recalling firm: Beckman Coulter Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-05-07
Terminated: 2023-03-27
Firm location: Brea, CA, United States

Product description

Access SARS CoV-2 lgG II Reagent, REF: C69057, IVD CE UDI: (01)15099590742744

Reason for recall

SARS-CoV-2 lgG II numerical results may potentially be multiplied by a factor of 1000 on systems running with assay protocol file (APF) and access assay file (AAF) versions resulting in falsely elevated numerical values.

Data sourced from openFDA. This site is unofficial and independent of the FDA.