FDA Device recall Z-1876-2025
VITROS Chemistry Products CRP Slides
- FDA Device
- Class II
- ongoing
- Published 2025-06-04
On 2025-06-04 the FDA classified a Class II recall of VITROS Chemistry Products CRP Slides by Ortho Clinical Diagnostics, citing product was incorrectly assigned GEN 88 instead of GEN 83 on product carton, foil wrapper, and cartridge (cart) label.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1876-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-04-14 |
| Published | 2025-06-04 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartridge, for a total of 90 slides.
Reason
Product was incorrectly assigned GEN 88 instead of GEN 83 on product carton, foil wrapper, and cartridge (cart) label.
Identifiers
| code_info | Catalog number: 8097990; GTIN#: 10758750004355; Coating Number: 1291; Lot No. 3788-1291-0019, 3788-1291-0052, 3788-1291…Catalog number: 8097990; GTIN#: 10758750004355; Coating Number: 1291; Lot No. 3788-1291-0019, 3788-1291-0052, 3788-1291-0078, 3788-1291-0079, 3788-1291-0080, 3788-1291-9975. |
|---|
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-1876-2025%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.