FDA Device recall Z-2123-2025
VITROS Chemistry Products CHE Slides (Japan)
- FDA Device
- Class II
- ongoing
- Published 2025-07-23
On 2025-07-23 the FDA classified a Class II recall of VITROS Chemistry Products CHE Slides (Japan) by Ortho Clinical Diagnostics, citing quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs when the PVs are us….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2123-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-06-10 |
| Published | 2025-07-23 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
VITROS Chemistry Products CHE Slides (Japan); Catalog Numbers: (1) 684 4074 (90 slides), (2) 684 4138 (300 slides);
Reason
Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs when the PVs are used 2-7 days after reconstitution; however, the label stability claims for the PV fluids is 7 days following reconstitution. This may lead to inaccurate QC results. The use of the PVs when the QC results are outside of the customer s established ranges could result in delayed results for patients due to the need to repeat QC testing or reconstitute new PV fluids and repeat testing. It could also result in erroneous patient results (small positive bias).
Identifiers
| code_info | Catalog Numbers: (1) 684 4074 (90 slides), (2) 684 4138 (300 slides); UDI-DI: (1) 10758750030293, (2) 10758750030309; Lot Numbers: All lots within expiry. |
|---|
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
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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-2123-2025%22
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