Recall Z-2624-2023— Ortho-Clinical Diagnostics, INc.

Name: FDA recall Z-2624-2023
Creator: U.S. Food and Drug Administration
Published: 2023-08-05

Class II · Ongoing

Class II FDA medical device recall by Ortho-Clinical Diagnostics, INc., initiated 2023-08-05. It names one FDA 510(k) clearance: K946090. Product: VITROS XT Chemistry Products ALKP Slides. Reason: Samples containing high levels of ALKP (or an interfering substance) could deplete the available substrate in the reagent layer of a VITROS ALKP Slide and not post the substrate deleption (DP) code, which may result in the System reporting an incorrect value (lower than the actual value), which may result in missed or delayed diagnosis of liver disease..

Recalling firm: Ortho-Clinical Diagnostics, INc.
Classification: Class II
Status: Ongoing
Initiated: 2023-08-05
Firm location: Rochester, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K946090 — KODAK EKTACCHEM 950IRC ANALYZERClinical Diagnostic Systems, Inc.·cleared 1995-01-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

VITROS XT Chemistry Products ALKP Slides

Reason for recall

Samples containing high levels of ALKP (or an interfering substance) could deplete the available substrate in the reagent layer of a VITROS ALKP Slide and not post the substrate deleption (DP) code, which may result in the System reporting an incorrect value (lower than the actual value), which may result in missed or delayed diagnosis of liver disease.

Data sourced from openFDA. This site is unofficial and independent of the FDA.