VITROS Immunodiagnostic Products Signal Reagent — Class III medical device recall Z-1707-2015
Terminated recall by ORTHO-CLINICAL DIAGNOSTICS, reported 2015-06-10, distributed nationwide. The Immunodiagnostic Products Signal Reagent, Lot 3082 as the reagent packs may contain blank labels.
| Recall number | Z-1707-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ORTHO-CLINICAL DIAGNOSTICS, Bridgend, N/A, United Kingdom |
| Recall initiated | 2015-05-06 |
| Classified | 2015-06-04 |
| Reported by FDA | 2015-06-10 |
| Terminated | 2017-09-13 |
| Distributed | Nationwide (US) |
| Quantity | 898 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 10758750008360 |
| Lot numbers | 3082 |
| Expiration dates | 2015-07-27 |
Product
VITROS Immunodiagnostic Products Signal Reagent, Product Code 1072693, Unique Device Identifier No. 10758750008360 VITROS Immunodiagnostics Products Signal Reagent (SR) is supplied to users as a sales unit box containing two Signal Reagent Packs. Each Signal Reagent Pack is labeled with a barcode label. The label should include the name of the reagent, a barcode, lot information and expiry dating.
Reason for recall
The Immunodiagnostic Products Signal Reagent, Lot 3082 as the reagent packs may contain blank labels.
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-1707-2015. 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.