Official recall record
VITROS XT Chemistry Products ALKP Slides
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2023-08-05
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 10758750008346
- Brand on record
- Ortho-Clinical Diagnostics, INc.
- Product category
- Medical Device
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
- 2024-12-19 · US FDA — Medical Devices
Brand Name: VITROS Product Name: VITROS XT 7600 Integrated System Model/Catalog Number: 6844461 (New), 62722 - 2024-12-19 · US FDA — Medical Devices
Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: 6802413 (New), 6802415 - 2024-12-19 · US FDA — Medical Devices
Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog Number: 6802783 (New), 68
All 19 official recall notices naming Ortho-Clinical Diagnostics, Inc. on this site →
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