VITROS XT Chemistry Slides Recalled for Dust Contamination of Diagnostic Results
Ortho-Clinical Diagnostics is recalling 88,253 units of VITROS XT Chemistry ALB-TP Slides because they shed dust and debris during normal operation, potentially contaminating sodium test results and causing misdiagnosis.
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 a Class II medical device recall involving potential diagnostic error with no reported patient illnesses or injuries. The hazard is theoretical—the source indicates results could cause serious harm but no actual harm has been reported, placing it at the High severity level for risk-of-harm products without reported injury.
Plain-English summary
Ortho-Clinical Diagnostics, Inc. is recalling 88,253 units of VITROS XT Chemistry Products ALB-TP Slides, which are used with VITROS XT 3400 or VITROS XT 7600 laboratory analyzers to measure albumin and total protein levels in patient samples.
During normal use, the ALB-TP slides shed dust and debris as they travel through the analyzer's MicroSlide Subsystem. This dust and debris may settle onto sodium (Na+) slides processed through the same system, potentially causing non-reproducible and biased sodium test results. The magnitude of error depends on the location and amount of contamination on the slide.
Inaccurate sodium measurements could result in incorrect diagnosis and inappropriate treatment, potentially leading to serious patient harm such as hypernatremia or hyponatremia. The contamination may also cause analyzer error codes that prevent slide processing and delay patient results. All current and expired ALB-TP slides are subject to this issue.
Healthcare providers and laboratory personnel with questions should contact Ortho-Clinical Diagnostics, Inc.
The recalled product
- Product
- The VITROS XT Chemistry Products ALB-TP Slides is a single device that contains both an albumin test and a total protein test side by side separated by a plastic barrier sealed within a single slide frame. In this format, individual reactions occur, and test results are generated
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
- Hazard
- contamination
- measurement-bias
- diagnostic-error
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 (1)
- UDI/GTIN# 10758750031771 All current and expired coatings
Distribution
Distributed nationwide across the United States.
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