VITROS recallZ-0236-2024 · Ortho-Clinical Diagnostics, INc. · initiated Sep 12, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Ortho-Clinical Diagnostics, INc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Products 1668409 and 8297749 may contain VITROS Lipase Slides with an abnormality which could cause -46% to +86% bias in lipase results depending on how the slides are used. Falsely low levels could result in a missed or delayed diagnosis of acute pancreatitis and may lead to diagnostic confusion in the setting of acute abdominal symptoms. Falsely elevated levels would not result in patient harm but may cause diagnostic confusion and a delay in accurate diagnosis of a patient with abdominal pain.
FDA root cause category: Under Investigation by firm
What the company is doing
An URGENT PRODUCT CORRECTION NOTIFICATION letter was sent to customers on 9/12/23. REQUIRED ACTIONS " Discontinue using, render unusable, and discard any remaining inventory of VITROS Lipase Slides, Lots 5905-3348-1557 and/or 5905-3348-2899, from your laboratory. " If you have one, use a lot other than 5905-3348-1557 and/or 5905-3348-2899 of VITROS Lipase slides for testing. " Complete and return the enclosed Confirmation of Receipt form no later than September 20, 2023. " Upon completion and return of the enclosed Confirmation of Receipt form, QuidelOrtho will send a replacement lot or credit your account. " Ensure your laboratory follows the calibration instructions provided in the VITROS Lipase Slides Instructions For Use. " Please forward this notification if the affected product was distributed outside of your facility. " Save this notification with your User Documentation or post this notification by each VITROS 250/350/5,1 FS/4600/5600/XT 3400/XT 7600 System until your laboratory receives a lot of VITROS Lipase Slides unaffected by this issue. " If your laboratory has experienced the issue with this product and you have not already done so, please report the occurrence to your local Global Services Organization. We apologize for the inconvenience this will cause your laboratory. If you have further questions, please contact our Global Services Organization at 1-800-421-3311.
Recall details
- Recall number
- Z-0236-2024
- Status
- Open, Classified
- Initiated by the company
- Sep 12, 2023
- Posted by the FDA
- Nov 6, 2023
- Recalling firm
- Ortho-Clinical Diagnostics, INc.
- Quantity
- 342 units
- Product code
- CHI
- Distribution
- US States: CA, CO, FL, GA, IL, IN, KS, NC, NY, TN, TX, VT. Canada, France, India, Japan, South Korea
Product description
VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749 (contains 18 slides per cartridge)
Code information (models, lots, serial numbers)
Product Code 1668409: UDI-DI: 10758750009510, Affected Lots: 5905-3348-1557; Product Code 8297749: UDI-DI: 10758750004683, Affected Lots: 5905-3348-2899
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- VITROS 8297749Ortho-Clinical Diagnostics, Inc. · LIPASE-ESTERASE, ENZYMATIC, PHOTOMETRIC, LIPASE1 recall0 reports
- VITROS 1668409Ortho-Clinical Diagnostics, Inc. · LIPASE-ESTERASE, ENZYMATIC, PHOTOMETRIC, LIPASE1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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