FDA Device recall Z-0913-2018
VITROS Chemistry Products DAT Performance Verifier III in vitro diagnostic
- FDA Device
- Class II
- terminated
- Published 2018-03-14
On 2018-03-14 the FDA classified a Class II recall of VITROS Chemistry Products DAT Performance Verifier III in vitro diagnostic by Ortho Clinical Diagnostics, citing this product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers causing customers to obtain lower than expected VITROS BENZ results when usi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0913-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-09-22 |
| Published | 2018-03-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
VITROS Chemistry Products DAT Performance Verifier III in vitro diagnostic
Reason
This product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers causing customers to obtain lower than expected VITROS BENZ results when using this control.
Identifiers
| code_info | Catalog# 6802329 Lot# K5618 |
|---|
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-0913-2018%22
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