FDAFDA · Food and drugs·Recall number Z-2366-2020
VITROS Chemistry Product Performance Verifier I, Product Code 8231474, UDI # 10758750004577 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems.
Published June 24, 2020 · Recall initiated: May 11, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 Sheets.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ortho-Clinical Diagnostics
- Distributor
- 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
- Lot
- Current Control Assay Sheet SD 4.2, 4.3 Revised Control Assay Sheet SD 6.8, 7.1
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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