FDA Device recall Z-2202-2019
VITROS Chemistry Products GLU Slides-Product Code:1707801
- FDA Device
- Class II
- terminated
- Published 2019-08-14
On 2019-08-14 the FDA classified a Class II recall of VITROS Chemistry Products GLU Slides-Product Code:1707801 by Ortho Clinical Diagnostics, citing potentially Biased Results using VITROS Chemistry Products GLU Slides.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2202-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-06-17 |
| Published | 2019-08-14 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
VITROS Chemistry Products GLU Slides-Product Code:1707801. IVD VITROS Chemistry Products GLU Slides quantitatively measure glucose (GLU) concentration in serum, plasma, urine, and cerebrospinal fluid using VITROS 250/350/5,1 FS/4600 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems
Reason
Potentially Biased Results using VITROS Chemistry Products GLU Slides
Identifiers
| code_info | Lot Number:0048-0964-9287; Exp Date:2020-11-01 UDI: 10758750009572 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2202-2019%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.