Recall Z-1293-2019
Ortho-Clinical Diagnostics · initiated February 20, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
VITROS ECi Immunodiagnostic System Refurbished Product Code: 6801059 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
Codes / lots: Serial Numbers: Systems that had the Luminometer component replaced during a service-repair. UDI: 10758750001040
Reason for recall
Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS Systems
FDA-determined cause: Software design
Action taken
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. -If you shutdown/restart and encounter any of the above Luminometer condition codes and are unable to process MicroWell assays, immediately contact the Ortho Care" Technical Solutions Center for service to your system. -Complete the enclosed Confirmation of Receipt form no later than March 1, 2019 by Fax: 1.888.557.3759 or 1.585.453.4110 or e-Mail Address: RA-OCDUS-CONFIRMAD@ORTHOCLINICALDIAGNOSTICS.COM. -Please forward this notification if the product was distributed outside of your facility. Foreign affiliates were informed by email on 21 February 2019 of the issue and instructed to notify affected consignees of the issue and appropriate actions to take. Questions contact Ortho Care" Technical Solutions Center at 1-800-421-3311.
Details
- Recall number
- Z-1293-2019
- Initiated
- February 20, 2019
- Terminated
- September 15, 2021
- Product code
- KHO – Fluorometer, For Clinical Use
- Quantity
- 25 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.
- Recalling firm
- Ortho-Clinical Diagnostics, Rochester, NY
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1287-2019 Class II | VITROS 5600 Integrated System -Software V3.3.2 & below Product Code: 6802413 For use in…Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS Systems | 02/20/2019Terminated |
| Z-1288-2019 Class II | VITROS 5600 Integrated System Refurbished-Software V3.3.2 & below Product Code: 6802915…Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS Systems | 02/20/2019Terminated |
| Z-1289-2019 Class II | VITROS 3600 Immunoassay System-Software V3.3.2 & below Product Code: 6802783 For use in…Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS Systems | 02/20/2019Terminated |
| Z-1290-2019 Class II | VITROS 3600 Immunoassay System Refurbished-Software V3.3.2 & below Product Code: 6802914…Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS Systems | 02/20/2019Terminated |
| Z-1291-2019 Class II | VITROS XT 7600 Integrated System-Software V3.4.1 & below Product Code: 6844461 For use…Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS Systems | 02/20/2019Terminated |
| Z-1292-2019 Class II | VITROS ECi/ECiQ Immunodiagnostic System Product Code: 1922814 For use in the in vitro…Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS Systems | 02/20/2019Terminated |