Recall Z-0236-2024 ยท CHI Lipase-Esterase, Enzymatic, Photometric, Lipase
Ortho-Clinical Diagnostics, INc.
VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749 (contains 18 slides per cartridge)
| Date | Nov 6, 2023 (initiated Sep 12, 2023) |
| Status | Open, Classified |
| 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. |
| 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 credi |
| Quantity | 342 units |
| Distribution | US States: CA, CO, FL, GA, IL, IN, KS, NC, NY, TN, TX, VT. Canada, France, India, Japan, South Korea |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.