FDAFebruary 20, 2019device
VITROS¿ 5600 Integrated System -Software V3.3.2 & below Product Code: 6802413 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems
What to do
FDA enforcement status: Terminated
Brands named
ortho clinical diagnosticsorthoortho clinical
UPCs
10758750002740
Recall history
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- FDA(1)(2) LeadCare¿ II Blood Lead Test Kit, (3)LeadCare¿ II 5X Blood Lead Test Kit, (4)LeadCare¿ II 9X Blood Lead Test Kit ; Catalog Number(s): (1) 70-6762, (2) 70-6762RUO, (3) 70-8404 (Box containing 5 Test Kits), (4) 70-9000 (Box containing 9 test kits); The LeadCare II kit is provided with the fo...2026-03-13
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