medical Class II Updated 2023-09-27

Ortho-Clinical Diagnostics, INc. recalls VITROS XT Chemistry Products TBIL-ALKP Slides

Recalled Product

VITROS XT Chemistry Products TBIL-ALKP Slides

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Product Code: 6844296 UDI: (10758750031801) GEN #16; Expiry Date Range 01 Jul 2023 - 01 Sep 2023 GEN #17; Expiry Date Range 01 Nov 2023 - 01 Feb 2024 GEN #18; Expiry Date Range 01 Apr 2024 - 01 Aug 2024 GEN #19; Expiry Date Range 01 Aug 2024 - 01 Jan 2025
View official government recall

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