Recall Z-0079-2019 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Ortho-Clinical Diagnostics
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
| Date | Aug 15, 2018 |
| Status | Terminated |
| Reason | Potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a MicroSlide without suppressing the potentially incorrect result. |
| Root cause | Software design |
| 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 als |
| Quantity | U.S.= 1255 ex-U.S.= 1504 |
| Distribution | Nationwide Foreign: France, Brazil, Chile, Great Britain, Phillippines, Spain |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081543 | VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEM Ortho-Clinical Diagnostics, Inc., Oct 23, 2008 |