Z-2367-2020 Class II Terminated
FDA device recall Z-2367-2020 was initiated by Ortho-Clinical Diagnostics on May 11, 2020 and is designated Class II. Reason for recall: Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as listed on the Performance Verifier (PV) Assay Sheet… The recall status is terminated (terminated September 22, 2021).
Recall Details
- Product Type
- Devices
- Report Date
- June 24, 2020
- Initiation Date
- May 11, 2020
- Termination Date
- September 22, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution - US Nationwide including in the statesof Maine, Massachusetts, Vermont, Connecticut, New Jersey, New York, Pennsylvania, Washington DC, Maryland, Virginia, West Virginia, North Carolina, South Carolina, Georgia, Florida, Alabama, Tennessee, Missouri, Mississippi, Kentucky, Ohio, Indiana, Michigan, Iowa, Wisconsin, Minnesota, South Dakota, North Dakota, Montana, Illinois, Kansas, Nebraska, Louisiana, Arkansas, Oklahoma, Texas, Colorado, Idaho, Utah, Arizona, New Mexico, California, Hawaii, Oregon , Washington, and Alaska