VITROS XT Chemistry Products ALB-TP Slides (ALB is not affected) - IVD quantitatively measures total protein (TP) concentration in serum and plasma using VITROS XT 3400 Chemistry Systems and VITROS XT 7600 Integrated Systems Product Code: 6844293
This recall has been terminated (originally issued December 15, 2020).
- Company
- Ortho Clinical Diagnostics Inc
- Recall Initiated
- December 15, 2020
- Terminated
- July 27, 2021
- Recall Number
- Z-0845-2021
- Quantity
- US=9802; OUS: 1298 Total: 11,100
- Firm Location
- Raritan, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Eltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Products ALB-TP Slides
Distribution
Worldwide distribution - US Nationwide distribution and the countries of AR, AU, BM, BR, CA, CL, CN, CO, CR, DO, EC, FR, FR, GT, HT, IN, JP, MX, PA, PE, PR, PY, SV.
Lot / Code Info
All Current, Future and Past Lots UDI: 10758750031771
Root Cause
Device Design
Action Taken
Ortho-Clinical Diagnostics (Ortho) issued customer letter (Ref. CL2018-308) was sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) on 15 Dec 2020 to all customers who received one of the affected products in the previous 18 months. Letter states reason for recall, health risk and action to take: Complete the enclosed Confirmation of Receipt form no later than insert date. Please provide the enclosed communication to customers who were shipped the affected products (listed above) from your facility within the last 18 months. Ortho has communicated with your customers that received drop shop product from our warehouse. Foreign affiliates were informed by email on 15 Dec 2020 of the issue and instructed to notify their consignees of the issue and their required action until the updated the IFU is available.