Laboratory Lipase Test Slides Recalled for Measurement Bias Risk
Ortho-Clinical Diagnostics is recalling VITROS Lipase Slides due to measurement abnormalities that could result in falsely low or elevated test results. This could delay diagnosis of acute pancreatitis or cause diagnostic confusion.
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: FDA Class II recall of a diagnostic medical device with a real functional abnormality that could result in missed or delayed diagnosis of acute pancreatitis. No illnesses or injuries have been reported, and falsely elevated results would not cause patient harm. This meets the rubric criterion for High severity: a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Ortho-Clinical Diagnostics, Inc. is recalling VITROS Chemistry Products Lipase Slides (Product Codes 1668409 and 8297749) distributed in the United States and internationally due to a manufacturing abnormality.
The affected slides may produce measurement bias of -46% to +86% in lipase test results. Falsely low results could cause a missed or delayed diagnosis of acute pancreatitis in patients with acute abdominal symptoms. Falsely elevated results would not cause direct patient harm but could cause diagnostic confusion and delay accurate diagnosis.
The recalled products were distributed across the United States (California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, North Carolina, New York, Tennessee, Texas, Vermont) and internationally to Canada, France, India, Japan, and South Korea. A total of 342 units are affected.
Healthcare facilities and laboratories using the affected product codes should stop using the recalled slides immediately and contact Ortho-Clinical Diagnostics for replacement or refund. Patients who may have had lipase tests performed with the affected slides should consult their healthcare provider if they have concerns about their test results.
The recalled product
- Product
- VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749 (contains 18 slides per cartridge)
- Manufacturer
- Ortho-Clinical Diagnostics, INc.
- Hazard
- measurement-bias
- delayed-diagnosis
- 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 (4)
- Product Code 1668409: UDI-DI: 10758750009510
- Affected Lots: 5905-3348-1557
- Product Code 8297749: UDI-DI: 10758750004683
- Affected Lots: 5905-3348-2899
Distribution
Distributed in 12 states:
- CA
- CO
- FL
- GA
- IL
- IN
- KS
- NC
- NY
- TN
- TX
- VT
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