FDA Device recall Z-1707-2015
VITROS Immunodiagnostic Products Signal Reagent, Product Code 1072693, Unique Device Identifier No. 10758750008360 VITROS Immunodiagnostics…
- FDA Device
- Class III
- terminated
- Published 2015-06-10
On 2015-06-10 the FDA classified a Class III recall of VITROS Immunodiagnostic Products Signal Reagent, Product Code 1072693, Unique Device Identifier No. 10758750008360 VITROS Immunodiagnostics… by Ortho Clinical Diagnostics, citing the Immunodiagnostic Products Signal Reagent, Lot 3082 as the reagent packs may contain blank labels.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1707-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-05-06 |
| Published | 2015-06-10 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
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
The Immunodiagnostic Products Signal Reagent, Lot 3082 as the reagent packs may contain blank labels.
Identifiers
| code_info | Lot 3082, expiry date 7/27/2015 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1707-2015%22
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