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Recall Observatory FDA recall evidence

Device product

VITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total N Antibody Calibrators programmed onto the Assay Data Disks (ADD) Data Release Versions (DRV): DRVs 6213 through 6218 supporting VITROS Calibrators. Product Code: 6199976

Z-1396-2023

March 09, 2023

Class II

Product summary

Firm
Ortho-Clinical Diagnostics, Inc.
Event
Event 92017
Status
Ongoing
Classification
Class II
Quantity
256 units
Official record key
device-enforcement:Z-1396-2023

Official wording

Reason: Incorrect Number of Calibrator Levels (2) Set for the VITROS Immunodiagnostics Products Anti-SARS-CoV-2 Total N Antibody Calibrators in Assay Data Disks (ADD), resulting in delayed patients results

Code information: UDI: 10758750034581 Lot # /Expiration Date: 0230 22-Feb-2023; 0240 22-Mar-2023; 0250 26-Apr-2023.

Distribution pattern: US Nationwide distribution in the states of AL, AZ, CA, GA, NY.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Incorrect Number of Calibrator Levels (2) Set for the VITROS Immunodiagnostics Products Anti-SARS-CoV-2 Total N Antibody Calibrators in Assay Data Disks (ADD), resulting in delayed patients results