FDA Device recall Z-1373-2024
VITROS Performance Verifier II
- FDA Device
- Class II
- ongoing
- Published 2024-04-03
On 2024-04-03 the FDA classified a Class II recall of VITROS Performance Verifier II by Ortho Clinical Diagnostics, citing the issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifier I and II. This issue has the potential to cause erroneous Quality Control (QC) r….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1373-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-02-27 |
| Published | 2024-04-03 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
VITROS Performance Verifier II
Reason
The issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifier I and II. This issue has the potential to cause erroneous Quality Control (QC) results that could lead to testing delays and erroneous patient results. This issue caused positive or negative bias in the quantification of sodium (Na+) and total carbon dioxide (ECO2). The incorrect diluent into the Performance Verifier II exhibited a potential negative bias of up to 6 mmol/L for ECO2 and Na+ testing.
Identifiers
| code_info | Product Code: 8231474; GTIN: 10758750004577; Lot No. R1176. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by Ortho Clinical Diagnostics
- Chemistry Products LAC Slides
FDA Device · Class II · 2025-09-24 · Ortho Clinical Diagnostics - VITROS Chemistry Products LAC Slides
FDA Device · Class II · 2025-09-24 · Ortho Clinical Diagnostics - VITROS Chemistry Products Ca Slides
FDA Device · Class II · 2025-08-27 · Ortho Clinical Diagnostics - VITROS Chemistry Products CHE Slides
FDA Device · Class II · 2025-07-23 · Ortho Clinical Diagnostics - Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier I Model/Catalog Number: 806 7324 Softwar…
FDA Device · Class II · 2025-07-23 · Ortho Clinical Diagnostics
All Ortho Clinical Diagnostics recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1373-2024%22
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