VITROS recallZ-2875-2020 · Ortho-Clinical Diagnostics · initiated Jul 13, 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 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
Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides
FDA root cause category: Other
What the company is doing
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: Instruction for Use will be update at a later date to indicate Eltrombopag as a known interferent. REQUIRED ACTIONS " Follow your normal laboratory procedures as you would for other known interferences." Complete the enclosed Confirmation of Receipt form no later than July 21, 2020. " Please forward this notification if the product was distributed outside of your facility. " Save this notification with your user documentation Questions, please contact Ortho Care" Technical Solutions Center at 1-800-421-3311
Recall details
- Recall number
- Z-2875-2020
- Status
- Terminated
- Initiated by the company
- Jul 13, 2020
- Recalling firm
- Ortho-Clinical Diagnostics
- Quantity
- US= 4076 OUS=949
- Product code
- CIG
- FDA submissions
- K190807
- 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.
Product description
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
Code information (models, lots, serial numbers)
All Current, Future and Past Lots UDI: 10758750031801
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- VITROS 6844296Ortho-Clinical Diagnostics, Inc. · NITROPHENYLPHOSPHATE, ALKALINE PHOSPHATASE OR ISOENZYMES4 recalls0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 86070).
- Z-2873-2020 · TerminatedVITROS Chemistry Products TBIL Slides- 5 PACK/300 SLDS In vitro Diagnostic quantitatively measure total bilirubin (TBIL) concentration in serum and plasma, Product code: 8159931
- Z-2874-2020 · TerminatedVITROS Chemistry Products BuBc Slides - in vitro diagnostic use only. VITROS Chemistry Products BuBc Slides quantitatively measure unconjugated bilirubin (Bu) and conjugated biliru…
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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