Recall Z-3280-2018 ยท JGS Electrode, Ion Specific, Sodium
Ortho-Clinical Diagnostics
VITROS Sodium Slides, Catalog # 837 9034
| Date | May 5, 2018 |
| Status | Terminated |
| Reason | Potential for positively biased results |
| Root cause | Nonconforming Material/Component |
| Action | On 05 May 2018, Customer letter (Ref. CL2018-123) 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 VITROS customers, who have a analyzer capable of running VITROS Na+ slides, to inform them of the issue and to request that they immediately discontinue use of this VITROS Na+ Slides, GENs 8 and 13. Continued use of VITROS Na+ Slides, GENs14,16,17& 18 is acceptable provided the conditions detailed in the communication are met. Foreign affiliates were initially informed by email on 05 May 2018 of the issue a |
| Distribution | US Nationwide, Bermuda, Austria, Brazil, Canada, Colombia, China, India, Japan, Mexico, Singapore, UK, France, Germany, Italy, Spain, Portugal, Poland, Russia, Denmark, Norway, Sweden, Belgium and the Netherlands |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K924471 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (NAIL) Eastman Kodak Company, Nov 6, 1992 |