Recall Z-2875-2020 ยท CIG Diazo Colorimetry, Bilirubin
Ortho-Clinical Diagnostics
VITROS XT Chemistry Products TBIL-ALKP Slides (ALKP is not affected) In Vitro Diagnostic use only - The TBIL test within the VITROS XT Chemistry Products TBIL-ALKP Slides quantitatively measures total bilirubin (TBIL) concentration in serum and plasma, Product Code: 6844296
| Date | Jul 13, 2020 |
| Status | Terminated |
| Reason | Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides |
| Root cause | Other |
| Action | Ortho Clinical Diagnostics issued URGENT PRODUCT CORRECTION NOTIFICATION on 13 July 2020, customer letter (Ref. CL2018-181) 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 one of the affected products in the previous 18 months. Foreign affiliates were informed by email on 13 July 2020 of the issue and instructed to notify their consignees of the issue and their required action until the updated the IFU is available. Letter states reason for recall, health risk and action to take: Instr |
| Quantity | US= 4076 OUS=949 |
| Distribution | Worldwide distribution - US Nationwide distribution and the countries of Australia, Belgium, Bermuda HM08, Brazil, Canada L3R 4G5, China, Denmark, France, Germany, Italy, Mexico, Norway, Poland, Portugal, Russia, Singapore 609917, Spain, Sweden, The Netherlands, United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190807 | VITROS XT Chemistry Products TBIL-ALKP Slides Ortho-Clinical Diagnostics, Inc., Apr 26, 2019 |