FDA Device recall Z-2624-2023
VITROS XT Chemistry Products ALKP Slides
- FDA Device
- Class II
- ongoing
- Published 2023-09-27
On 2023-09-27 the FDA classified a Class II recall of VITROS XT Chemistry Products ALKP Slides by Ortho Clinical Diagnostics, citing 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 d….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2624-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-08-05 |
| Published | 2023-09-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
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.
Identifiers
| code_info | Product Code: 1053180 UDI:(10758750008346) GEN #21; Expiry Date Range 01 Jul 2023 - 01 June 2024 GEN #23; Expiry Date…Product Code: 1053180 UDI:(10758750008346) GEN #21; Expiry Date Range 01 Jul 2023 - 01 June 2024 GEN #23; Expiry Date Range 01 Oct 2023 - 01 Sep 2024 GEN #26; Expiry Date Range 01 Aug 2023 - 01 Dec 2024 GEN #28; Expiry Date Range 01 Aug 2024 GEN #29; Expiry Date Range 01 Sep 2024 - 01 Dec 2024 GEN #30; Expiry Date Range 02 Jan 2025 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2624-2023%22
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