Z-0236-2024Class II

VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749...

Name: Z-0236-2024 VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749...
Creator: Ortho-Clinical Diagnostics, INc.
Published: 2023-09-12
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2023-09-12 / Open, Classified

FDA source

Ortho-Clinical Diagnostics, INc. began a recall of VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749 (contains 18 slides per cartridge) on 2023-09-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0236-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-09-12
Posted: 2023-11-06
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749 (contains 18 slides per cartridge)
Product code: CHI Lipase-Esterase, Enzymatic, Photometric, Lipase
Reason for recall: 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: Under Investigation by firm
Action: 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.
Quantity in commerce: 342 units
Distribution: US States: CA, CO, FL, GA, IL, IN, KS, NC, NY, TN, TX, VT. Canada, France, India, Japan, South Korea
Product codes and lots: Product Code 1668409: UDI-DI: 10758750009510, Affected Lots: 5905-3348-1557; Product Code 8297749: UDI-DI: 10758750004683, Affected Lots: 5905-3348-2899

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0236-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0236-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-06

Product code CHI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)