Elecsys PreciControl Varia 3 — Class II medical device recall Z-2173-2017
Terminated recall by Roche Diagnostics Corporation, reported 2017-06-07, distributed nationwide. e-barcode and value sheet for PreciControl Varia contains a typographical error for the target values for the
| Recall number | Z-2173-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Diagnostics Corporation, Indianapolis, IN, United States |
| Recall initiated | 2017-04-10 |
| Classified | 2017-05-31 |
| Reported by FDA | 2017-06-07 |
| Terminated | 2017-08-04 |
| Distributed | Nationwide (US) |
| Quantity | 1,603 |
| Lot numbers | 189285 |
| Expiration dates | 2017-10-31 |
Product
Elecsys PreciControl Varia 3
Reason for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2173-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.