FDA Device recall Z-2344-2018
VITROS Chemistry Products PHYT Slides, Catalog Number 8298671. in vitro diagnostic
- FDA Device
- Class II
- terminated
- Published 2018-07-11
On 2018-07-11 the FDA classified a Class II recall of VITROS Chemistry Products PHYT Slides, Catalog Number 8298671. in vitro diagnostic by Ortho Clinical Diagnostics, citing there is a potential for imprecise results when using the slides. Increase in imprecision when using PHYT coating 0165. This leads to higher and lower than expected results for bo….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2344-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-05-09 |
| Published | 2018-07-11 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
VITROS Chemistry Products PHYT Slides, Catalog Number 8298671. in vitro diagnostic
Reason
There is a potential for imprecise results when using the slides. Increase in imprecision when using PHYT coating 0165. This leads to higher and lower than expected results for both quality control samples and patient samples.
Identifiers
| code_info | Lot Numbers: 2616-0165-4866, 2616-0165-4904, 2616-0165-4870, 2616-0165-4869, 2616-0165-5266, 2616-0165-5307, 2616-0165-…Lot Numbers: 2616-0165-4866, 2616-0165-4904, 2616-0165-4870, 2616-0165-4869, 2616-0165-5266, 2616-0165-5307, 2616-0165-5233, 2616-0165-5232, 2616-0165-5611, 2616-0165-5610, 2616-0165-5648, 2616-0165-5649, 2616-0165-6218, 2616-0165-6275, 2616-0165-6220, 2616-0165-6221, 2616-0165-6219, 2616-0165-6276, 2616-0165-6791, 2616-0165-6832, 2616-0165-6792, 2616-0165-6787, 2616-0165-7225, 2616-0165-7226, 2616-0165-7223, 2616-0165-7214, 2616-0165-7222 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2344-2018%22
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