FDA Device recall Z-1834-2020
VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468
- FDA Device
- Class III
- terminated
- Published 2020-05-06
On 2020-05-06 the FDA classified a Class III recall of VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468 by Ortho Clinical Diagnostics, citing the specified reagent packs exhibit an increase in the frequency of unsuccessful calibrations.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1834-2020 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2020-03-10 |
| Published | 2020-05-06 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468
Reason
The specified reagent packs exhibit an increase in the frequency of unsuccessful calibrations.
Identifiers
| code_info | UDI: 10758750005147; Lot Number: 2340 |
|---|
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-1834-2020%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.