Z-1688-2021 Class II Terminated
FDA device recall Z-1688-2021 was initiated by Ortho-Clinical Diagnostics, INc. on May 3, 2021 and is designated Class II. 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 Im… The recall status is terminated (terminated October 24, 2023). Affected quantity: 74 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 2, 2021
- Initiation Date
- May 3, 2021
- Termination Date
- October 24, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 74 units
Product Description
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.
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 Pattern
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.
Code Information
Unique Identifier: 10758750033591 Lot: 0020