FDA Device recall Z-2173-2017
Elecsys PreciControl Varia 3
- FDA Device
- Class II
- terminated
- Published 2017-06-07
On 2017-06-07 the FDA classified a Class II recall of Elecsys PreciControl Varia 3 by Roche Diagnostics, citing e-barcode and value sheet for PreciControl Varia contains a typographical error for the target values for the Elecsys PTH (parathyroid hormone) and Elecsys PTH STAT immunoassays.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2173-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-04-10 |
| Published | 2017-06-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Roche Diagnostics |
| Distribution | US |
Product
Elecsys PreciControl Varia 3
Reason
e-barcode and value sheet for PreciControl Varia contains a typographical error for the target values for the Elecsys PTH (parathyroid hormone) and Elecsys PTH STAT immunoassays
Identifiers
| code_info | Lot Number: 189285 Expiration Date: 10/31/2017 Part Number: PreciControl Varia: 05618860160 |
|---|
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-2173-2017%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.