Ortho-Clinical Diagnostics Recalls VITROS TBIL Slides Due to Etrombopag Interference
Ortho-Clinical Diagnostics is recalling VITROS TBIL Slides because the drug etrombopag can interfere with test results, potentially leading to inaccurate total bilirubin measurements.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall is classified as FDA Class II, and the hazard involves potential misdiagnosis due to drug interference, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products TBIL Slides (Product code: 8159931) because the drug etrombopag can interfere with the test results. This in vitro diagnostic product is used to quantitatively measure total bilirubin (TBIL) concentration in serum and plasma.
The recall affects all current, future, and past lots of the product. The distribution was worldwide, including the United States and various international locations such as Australia, Canada, China, and the United Kingdom.
Healthcare facilities and laboratories should stop using the affected slides and contact Ortho-Clinical Diagnostics for further instructions on how to handle the product.
The recalled product
- Product
- VITROS Chemistry Products TBIL Slides- 5 PACK/300 SLDS In vitro Diagnostic quantitatively measure total bilirubin (TBIL) concentration in serum and plasma, Product code: 8159931
- Manufacturer
- Ortho-Clinical Diagnostics
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 (2)
- All Current
- Future and Past Lots UDI: 10758750031801
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Ortho-Clinical Diagnostics under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Ortho-Clinical Diagnostics
See all →- HighLaboratory performance verifier recalled for mismatched diluent assembly
FDA (Devices) · 2024-04-03
- HighClinical Laboratory Quality Control Device Recalled for Diluent Assembly Error
FDA (Devices) · 2024-04-03
- HighVITROS Troponin I ES Immunodiagnostic Reagent Pack Recalled for Incorrect Wells
FDA (Devices) · 2023-08-16
- HighFDA Recalls Troponin Cardiac Test Calibrators for Potential False Negatives
FDA (Devices) · 2023-08-16
- HighOrtho Recalls VITROS Chemistry Calibrator Kit 20 for Analytical Bias
FDA (Devices) · 2023-07-19
Same hazard · drug interference
See all →- HighRAPIDPOINT 500 Blood Gas System: Drug Interference May Cause False Sodium Readings
FDA (Devices) · 2023-12-06
- HighRAPIDPOINT 500e Blood Gas System Recalled Due to Drug Interference
FDA (Devices) · 2023-12-06
- HighMedtronic Enlite Glucose Sensor Recall Due to Hydroxyurea Interference
FDA (Devices) · 2021-05-26
- ModerateOrtho VITROS Chemistry TP Slides Recalled for Eltrombopag Interference
FDA (Devices) · 2021-01-20
- HighDexcom G6 Continuous Glucose Monitoring System Recalled for Hydroxyurea Interference
FDA (Devices) · 2020-04-01
Similar recalls
- ModerateOrtho-Clinical Diagnostics Recalls VITROS TBIL Slides for Dispense Issues
FDA (Devices) · 2013-11-27
- ModerateOrtho VITROS Chemistry TP Slides Recalled for Eltrombopag Interference
FDA (Devices) · 2021-01-20
- ModerateOrtho Clinical Diagnostics Recalls VITROS XT Chemistry Products ALB-TP Slides
FDA (Devices) · 2021-01-20
- ModerateOrtho-Clinical Diagnostics Recalls VITROS Chemistry Product Slides
FDA (Devices) · 2013-11-27
- ModerateOrtho-Clinical Diagnostics Recalls VITROS Chemistry ALB Slides
FDA (Devices) · 2013-11-27
- ModerateOrtho-Clinical Diagnostics Recalls VITROS Carbamazepine Slides Due to Potential Bias
FDA (Devices) · 2014-04-23