Recall Z-1521-2015 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Ortho-Clinical Diagnostics
Software Version 2.8 & Below on VITROS 5,1 FS Chemistry Systems, Catalog Number 6801375, Global Trade Item Number 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number 6801890, Global Trade Item Number 10758750001644; IVD. Intended for use in the in vitro quantitative, semi quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITR
| Date | Apr 25, 2015 (initiated Mar 10, 2015) |
| Status | Terminated |
| Reason | Software Anomaly; It is possible for the device to process samples with a cartridge other than the intended cartridge, potentially leading to erroneous patient results. If this anomaly occurred previously, an indication would be a series of results that were similar across multiple samples (i.e., results could be believable or outside of the Reportable Range for the intended assay). |
| Root cause | Software in the Use Environment |
| Action | On 3/10/2015, URGENT PRODUCT CORRECTION NOTIFICATION letters (Ref. CL2015-047, dated 3/10/2015) were sent to users notifying them of the issue and advising them of the required actions. Customers are to complete and return the Confirmation of Receipt no later than March 23, 2015. The firm is currently working on a resolution and will issue a follow up notification upon the software's availability. For questions, please contact Customer Technical Services at 1-800-421-3311. |
| Quantity | VITROS 5.1 System: Domestic - 909; Foreign - 1250; 5,1 Refurbished: Domestic - 66 units, Foreign - 152 |
| Distribution | Worldwide Distribution -- USA, Puerto Rico, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Singapore, Spain, and Venezuela. |
| FDA record | Open on fda.gov |