Ortho-Clinical Diagnostics, INc.: VITROS CoV2 Ag calibrator (Product Code 6199950) - Product Usage: is a chemiluminescent immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid

Is my product affected?

VITROS CoV2 Ag calibrator (Product Code 6199950) - Product Usage: is a chemiluminescent immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in nasopharyngeal (NP) and anterior nasal swab specimens collected in CDCs formulation of VTM.

• UPC 10758750033591

Check against the official notice below — it lists the full affected range.

What happened

Ortho-Clinical Diagnostics recalled VITROS CoV2 Ag Calibrator (Product Code 6199950, Lot 0020) due to a confirmed potential for unexpected failed calibration and associated condition codes when used with VITROS SARS-CoV-2 Ag Reagent Pack. The calibrator is a chemiluminescent immunoassay device intended for qualitative detection of SARS-CoV-2 nucleocapsid antigen. A total of 74 units were affected.

The recalled product was distributed worldwide, including US locations in Arkansas, California, Iowa, Illinois, Louisiana, Missouri, Mississippi, Texas, and Wisconsin, as well as in Colombia, India, Japan, Italy, Spain, Portugal, and France. The recall source does not specify a remedy or actions consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Ortho investigated and confirmed the potential for unexpected failed calibration, and condition codes associated with the calibration, when using VITROS SARS-CoV-2 Ag Reagent Pack along with VITROS Immunodiagnostic Products SARS-CoV-2 Ag Calibrator, Lot 20.

Details from the source

Reason for recall: Ortho investigated and confirmed the potential for unexpected failed calibration, and condition codes associated with the calibration, when using VITROS SARS-CoV-2 Ag Reagent Pack along with VITROS Immunodiagnostic Products SARS-CoV-2 Ag Calibrator, Lot 20. Distribution: Worldwide distribution - US Nationwide distribution in the states of AR, CA, IA, IL, LA, MO, MS, TX, WI, and the countries of Colombia, India, Japan, Italy, Spain, Portugal, France. Quantity: 74 units Lot/code info: Unique Identifier: 10758750033591 Lot: 0020

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• Angiographic Guidewire Component: Model Number: 107042, 107044, 107447, 110003, 110004, The angiographic guidewire components associated with this recall are manufactured with a requirement that further downstream processing (sterilization) is required. Indications for use for these components are n2021-05-04
• Omnera 400T Digital Radiographic System2021-05-05
• Omnera 400A Digital Radiographic System2021-05-05
• Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems. Brilliance 64, Brilliance 40, Ingenuity Flex 728235 - Brilliance 40 728231/728232 - Brilliance 64 728317/728318 - Ingenuity Flex2021-05-01
• Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems. BB (Big Bore) Oncology, BB (Big Bore) Radiology: 728242/728243/728244/728272 - Brilliance Big Bore2021-05-01

All FDA (Device enforcement) recalls