Recall Z-2256-2021— Beckman Coulter Inc.

Name: FDA recall Z-2256-2021
Creator: U.S. Food and Drug Administration
Published: 2021-07-01

Class II · Terminated

Class II FDA medical device recall by Beckman Coulter Inc., initiated 2021-07-01, terminated 2023-06-14. FDA's recall record names no specific 510(k) clearance for this event. Product: Access SARS-CoV-2 Antigen Calibrators, Catalog, REF: C68669, Contents: 1x2.5 mL C0, 1x2.5mL C1, 1x CAL CARD, UDI: (01)15099590742720;. Reason: SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis ..

Recalling firm: Beckman Coulter Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-07-01
Terminated: 2023-06-14
Firm location: Brea, CA, United States

Product description

Access SARS-CoV-2 Antigen Calibrators, Catalog, REF: C68669, Contents: 1x2.5 mL C0, 1x2.5mL C1, 1x CAL CARD, UDI: (01)15099590742720;

Reason for recall

SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis .

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