VITROS Chemistry Products Lipase Slides…

Date

Nov. 15, 2023

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Ongoing

Filed by

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)

Reason

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.

Distribution pattern

US States: CA, CO, FL, GA, IL, IN, KS, NC, NY, TN, TX, VT. Canada, France, India, Japan, South Korea

Quantity

342 units

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

Recall started

Sept. 12, 2023

Device type

Lipase-Esterase, Enzymatic, Photometric, Lipase

Root cause (FDA)

Under Investigation by firm

What the company told customers

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 number

Z-0236-2024

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0236-2024. The agency record governs; check it and the company before acting.