Recall Z-0875-2021— Beckman Coulter Inc.
Class II · Terminated
Class II FDA medical device recall by Beckman Coulter Inc., initiated 2020-12-30, terminated 2022-09-19. FDA's recall record names no specific 510(k) clearance for this event. Product: ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 - Product Usage: use on the Access Family of Immunoassay Systems only.. Reason: The Quality Control (QC) card has a label error for the standard deviation (SD) values for one out of the two levels of QC..
- Recalling firm
- Beckman Coulter Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-12-30
- Terminated
- 2022-09-19
- Firm location
- Brea, CA, United States
Product description
ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 - Product Usage: use on the Access Family of Immunoassay Systems only.
Reason for recall
The Quality Control (QC) card has a label error for the standard deviation (SD) values for one out of the two levels of QC.
Data sourced from openFDA. This site is unofficial and independent of the FDA.