Recall Z-1292-2019 ยท KHO Fluorometer, For Clinical Use
Ortho-Clinical Diagnostics
VITROS ECi/ECiQ Immunodiagnostic System Product Code: 1922814 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
| Date | Feb 20, 2019 |
| Status | Terminated |
| Reason | Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS Systems |
| Root cause | Software design |
| Action | Ortho Clinical Diagnostics (Ortho) issued an "URGENT PRODUCT CORRECTION NOTIFICATION" , a customer letter (Ref. CL2019-052) dated 21 February 2019 via FedEx overnight courier and/or US Postal Service Priority Mail (for PO Boxes only) to customers who were shipped affected VITROS Systems/or whose VITROS System has a luminometer parts replacement. The customers were notified of the issue and instructed to notify Ortho upon experiencing the issue described: -Avoid performing a shutdown/restart on your systems unless directed by an Ortho representative or prompted by condition code help text. -I |
| Quantity | 45 units |
| Distribution | Worldwide Distribution: US (Nationwide) and countries of: Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden,The Netherlands, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K962919 | VITROS IMMUNODIAGNOSTIC SYSTEM Johnson & Johnson Clinical Diagnostics, Inc., Oct 18, 1996 |