VITROS XT Chemistry TBIL-ALKP Slides recalled for incorrect liver enzyme readings
Ortho-Clinical Diagnostics is recalling VITROS XT Chemistry TBIL-ALKP Slides because they may report incorrectly low liver enzyme values, potentially leading to missed or delayed liver disease diagnoses. Approximately 52,456 units were distributed worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall with no reported illnesses or injuries. The hazard represents a risk of missed or delayed diagnosis of a serious condition. Per the severity rubric, risk-of-harm products where injury has not yet been reported score 3 (High).
Plain-English summary
Ortho-Clinical Diagnostics, Inc. is recalling VITROS XT Chemistry Products TBIL-ALKP Slides. These are diagnostic reagent products used in clinical laboratory testing to measure alkaline phosphatase and total bilirubin levels, which indicate liver function.
The recall was issued because certain samples containing high levels of alkaline phosphatase (ALKP) or interfering substances can deplete the substrate in the slide's reagent layer without triggering the device's substrate depletion alarm code. When this occurs, the system may report an incorrect value that is lower than the actual result, potentially leading to missed or delayed diagnosis of liver disease.
Approximately 52,456 units have been distributed worldwide, including throughout the United States and to more than 20 countries (Bermuda, Belgium, Australia, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, Italy, India, Japan, Mexico, Netherlands, Norway, Singapore, Spain, Sweden, Portugal, Russia, and the United Kingdom). The affected lots have expiry dates ranging from July 2023 through January 2025.
The recalled product
- Product
- VITROS XT Chemistry Products TBIL-ALKP Slides
- Manufacturer
- Ortho-Clinical Diagnostics, INc.
- Hazard
- diagnostic-error
- delayed-diagnosis
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- 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
Distribution
Distributed nationwide across the United States.
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