Ortho-Clinical Diagnostics, INc.: VITROS Lipase Slides Recalled for Incorrect Results and Diagnosis Risk

Agency Publication Date: November 6, 2023

Summary

Approximately 342 units of VITROS Chemistry Products Lipase Slides (Product Codes 1668409 and 8297749) have been recalled by Ortho-Clinical Diagnostics, Inc. The slides may have an abnormality causing lipase test results to be biased between -46% and +86% depending on use. Falsely low lipase levels could lead to a missed or delayed diagnosis of acute pancreatitis, while falsely high levels may cause diagnostic confusion and delays in accurate treatment for patients with abdominal pain. Consumers should be aware that these diagnostic slides were distributed across several US states and internationally between September and November 2023.

Risk

The defect causes inaccurate laboratory readings of lipase levels, which are critical for diagnosing pancreatic issues. This measurement bias can lead healthcare providers to either overlook a serious inflammatory condition (acute pancreatitis) or misattribute abdominal symptoms, delaying the correct medical intervention.

What You Should Do

Identify if your facility uses VITROS Chemistry Products Lipase Slides with Product Code 1668409 (60 Slides per Cartridge) and check for Affected Lot 5905-3348-1557 with UDI-DI 10758750009510.
Identify if your facility uses VITROS Chemistry Products Lipase Slides with Product Code 8297749 (18 Slides per Cartridge) and check for Affected Lot 5905-3348-2899 with UDI-DI 10758750004683.
If you are a patient who recently underwent lipase testing and have concerns about the accuracy of your results or persistent abdominal symptoms, contact your healthcare provider immediately to discuss your diagnosis.
Healthcare facilities and laboratories should stop using the affected lots immediately and contact Ortho-Clinical Diagnostics, Inc. for further instructions regarding the return or replacement of these slides.
For technical questions or to report issues with the products, contact the manufacturer, Ortho-Clinical Diagnostics, Inc., using the contact information provided in the initial firm notification letter.
Contact the FDA for additional questions or to report adverse events at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer Notification and Correction

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: VITROS Chemistry Products Lipase Slides (60 Slides per Cartridge)

Model / REF:

1668409

Lot Numbers:

5905-3348-1557

Product: VITROS Chemistry Products Lipase Slides (18 slides per cartridge)

Model / REF:

8297749

Lot Numbers:

5905-3348-2899

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93238

Status: Active

Manufacturer: Ortho-Clinical Diagnostics, INc.

Sold By: Clinical laboratories; Healthcare facilities

Manufactured In: United States

Units Affected: 342 units

Distributed To: California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, North Carolina, New York, Tennessee, Texas, Vermont

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

Identify if your facility uses VITROS Chemistry Products Lipase Slides with Product Code 1668409 (60 Slides per Cartridge) and check for Affected Lot 5905-3348-1557 with UDI-DI 10758750009510.

Identify if your facility uses VITROS Chemistry Products Lipase Slides with Product Code 8297749 (18 Slides per Cartridge) and check for Affected Lot 5905-3348-2899 with UDI-DI 10758750004683.

If you are a patient who recently underwent lipase testing and have concerns about the accuracy of your results or persistent abdominal symptoms, contact your healthcare provider immediately to discuss your diagnosis.

Healthcare facilities and laboratories should stop using the affected lots immediately and contact Ortho-Clinical Diagnostics, Inc. for further instructions regarding the return or replacement of these slides.

For technical questions or to report issues with the products, contact the manufacturer, Ortho-Clinical Diagnostics, Inc., using the contact information provided in the initial firm notification letter.

Contact the FDA for additional questions or to report adverse events at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.