Vitros Chemistry Products Lipase Slides

Issue

Ortho Clinical Diagnostics (Quidelortho) determined that lots 5905-3348-1557 and 5905-3348-2899 of Vitros Lipase Slides include carts which may contain consecutive slides that may not function as intended. Quidelortho estimates that approximately 1.4% of Vitros Lipase Slides within each lot may be affected. These affected Vitros Lipase Slides (approximately 15-40 consecutive slides within a cart or across consecutive carts) have an abnormality which may cause positive or negatively biased results. Due to the nature of the abnormality, which can vary across the affected slides, the magnitude of potential bias can vary from slide to slide. The direction of potential bias will depend on the following two scenarios: Scenario 1: A successful calibration is obtained using unaffected slides within the lot. As the slide lot is used, a cart containing affected slides is introduced. The affected slides may produce results with a negative bias. Quidelortho's investigation has determined a potential maximum negative bias of up to approximately 46%. Scenario 2: Depending on if/when an affected slide is introduced during calibration, the potential exists to obtain a successful calibration using affected slides. As the slide lot is then used, a cart containing unaffected slides is introduced. According to our calibration simulations, the unaffected slides may produce results with a positive bias up to and potentially exceeding 86%. Performing quality control testing may not detect that the successful calibration was performed on affected slides. Recall Start Date: September 13, 2023

What you should do

• Review/post recall notice, discontinue use/discard any remaining inventory, complete/return reply form.