FDA Device recall Z-2266-2024
VITROS Chemistry Products FS Diluent Pack 3, Model/Catalog Number: 6801754
- FDA Device
- Class II
- ongoing
- Published 2024-07-10
On 2024-07-10 the FDA classified a Class II recall of VITROS Chemistry Products FS Diluent Pack 3, Model/Catalog Number: 6801754 by Ortho Clinical Diagnostics, citing VITROS Chemistry Products FS Diluent Pack 3, Lot 01-1645 may cause results to be negatively biased when used to dilute patient samples tested with VITROS Chemistry Products CRP Sl….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2266-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-05-21 |
| Published | 2024-07-10 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
VITROS Chemistry Products FS Diluent Pack 3, Model/Catalog Number: 6801754. Product Description: VITROS Chemistry Products FS Diluent Pack 3 comes with 3 packs per sales unit.
Reason
VITROS Chemistry Products FS Diluent Pack 3, Lot 01-1645 may cause results to be negatively biased when used to dilute patient samples tested with VITROS Chemistry Products CRP Slides.
Identifiers
| code_info | Lot Code: Model No 6801754; UDI-DI 10758750007004; Lot Number 01-1645; Expiration Date: 05-Jul-2024 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2266-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.