Recall Z-0845-2021
Ortho Clinical Diagnostics Inc · initiated December 15, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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
Codes / lots: All Current, Future and Past Lots UDI: 10758750031771
Reason for recall
Eltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Products ALB-TP Slides
FDA-determined 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.
Details
- Recall number
- Z-0845-2021
- Initiated
- December 15, 2020
- Terminated
- July 27, 2021
- Product code
- CEK – Biuret (Colorimetric), Total Protein
- Quantity
- US=9802; OUS: 1298 Total: 11,100
- 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.
- Recalling firm
- Ortho Clinical Diagnostics Inc, Raritan, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0844-2021 Class II | VITROS Chemistry Products TP Slides- IVD measure total protein (TP) concentration in…Eltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Products ALB-TP… | 12/15/2020Terminated |