Ortho-Clinical Diagnostics Recall: VITROS 5600 Chemistry System, Catalog Number 6802413, U
Ortho-Clinical Diagnostics Recall: VITROS 5600 Chemistry System, Catalog Number 6802413, U is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Ortho-Clinical Diagnostics; Product: VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number 10758750002740; IVD. Pro
| Recalling firm | Ortho-Clinical Diagnostics |
|---|---|
| Product | VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number 10758750002740; IVD. Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents. |
| Reason for recall | Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chemistry Systems when using Calibrator Kit 9, Lot 954. A trend of complaints regarding customers actions following U90-382 or 6LU condition codes was noted (See RES 72289 - VITROS Calibrator Kit 9, lot 954 recall). |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Worldwide Distribution - US Nationwide including Puerto Rico, and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela |
| Recall initiated | 20151221 |
| Recall number | Z-1074-2016 |
| Category | device |
| State | NY |
| Country | United States |
$29/mo
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