VITROS 5600 Integrated System-For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, Catalog Number: 6802413
FDA Recall Z-0079-2019 · Posted None
Recalling FirmOrtho-Clinical Diagnostics
Recall StatusTerminated
Product CodeJLW
Date Initiated2018-08-15
Date Terminated2022-01-10
Product QuantityU.S.= 1255 ex-U.S.= 1504
Reason for Recall
Potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a MicroSlide without suppressing the potentially incorrect result.
Firm Action
ORTHO PLUSSM is e-Communications, a service that provides subscribing customers with Ortho Clinical Diagnostics (Ortho) product notifications electronically on 15 August 2018, a customer letter (Ref. CL2018-174) was sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to all customers who received VITROS 5600 Integrated Systems to inform them of the potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a MicroSlide without suppressing the potentially incorrect result. Ortho also provided specific actions for customers to take when they observe unexpected MicroSlide assay results for a sample associated with TE1-504 and/or TE1-594 condition codes. Customers were also instructed to discuss any concerns related to this issue and previously reported results with the Laboratory Medical Director.
Root Cause
Software design
Distribution Pattern
Nationwide Foreign: France, Brazil, Chile, Great Britain, Phillippines, Spain
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.