VITROS XT Chemistry Products TBIL-ALKP Slides
FDA Device Recall #Z-2623-2023 — Class II — August 5, 2023
Recall Summary
| Recall Number | Z-2623-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 5, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Ortho-Clinical Diagnostics, INc. |
| Location | Rochester, NY |
| Product Type | Devices |
| Quantity | 52,456 units |
Product Description
VITROS XT Chemistry Products TBIL-ALKP Slides
Reason for Recall
Samples containing high levels of ALKP (or an interfering substance) could deplete the available substrate in the reagent layer of a VITROS ALKP Slide and not post the substrate deleption (DP) code, which may result in the System reporting an incorrect value (lower than the actual value), which may result in missed or delayed diagnosis of liver disease.
Distribution Pattern
Worldwide Distribution: US (nationwide) and OUS (foreign) distribution to countries of: Bermuda, Belgium, Australia, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, Italy, India, Japan, Mexico, Netherlands, Norway, Singapore, Spain, Sweden, Portugal, Russia, United Kingdom
Lot / Code Information
Product Code: 6844296 UDI: (10758750031801) GEN #16; Expiry Date Range 01 Jul 2023 - 01 Sep 2023 GEN #17; Expiry Date Range 01 Nov 2023 - 01 Feb 2024 GEN #18; Expiry Date Range 01 Apr 2024 - 01 Aug 2024 GEN #19; Expiry Date Range 01 Aug 2024 - 01 Jan 2025
Other Recalls from Ortho-Clinical Diagnostics, INc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2559-2025 | Class II | Chemistry Products LAC Slides. Catalog Number: ... | Jul 29, 2025 |
| Z-2560-2025 | Class II | VITROS Chemistry Products LAC Slides. Catalog N... | Jul 29, 2025 |
| Z-2335-2025 | Class II | VITROS Chemistry Products Ca Slides; Catalog N... | Jul 9, 2025 |
| Z-2073-2025 | Class II | VITROS Chemistry Products OP Reagent Gen 15. Mo... | Jun 12, 2025 |
| Z-2121-2025 | Class II | Brand Name: VITROS Chemistry Products Product ... | Jun 10, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.