VITROS recallZ-0845-2021 · Ortho Clinical Diagnostics Inc · initiated Dec 15, 2020
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Ortho Clinical Diagnostics Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Eltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Products ALB-TP Slides
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-0845-2021
- Status
- Terminated
- Initiated by the company
- Dec 15, 2020
- Recalling firm
- Ortho Clinical Diagnostics Inc
- Quantity
- US=9802; OUS: 1298 Total: 11,100
- Product code
- CEK
- 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.
Product description
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
Code information (models, lots, serial numbers)
All Current, Future and Past Lots UDI: 10758750031771
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- VITROS 6844293Ortho-Clinical Diagnostics, Inc. · BROMCRESOL GREEN DYE-BINDING, ALBUMIN2 recalls0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 87019).
- Z-0844-2021 · TerminatedVITROS Chemistry Products TP Slides- IVD measure total protein (TP) concentration in serum and plasma using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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