FDA Device recall Z-1436-2014
Boule Con-Diff Tri-Level Multi-Parameter Assayed Hematology Control, used for in vitro diagnostic use as a control to monitor the performan…
- FDA Device
- Class II
- terminated
- Published 2014-04-16
On 2014-04-16 the FDA classified a Class II recall of Boule Con-Diff Tri-Level Multi-Parameter Assayed Hematology Control, used for in vitro diagnostic use as a control to monitor the performan… by Clinical Diagnostic Solutions, citing elevated MCV results on the 1311-682, 1311-683, and 1311-684 lots.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1436-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-02-24 |
| Published | 2014-04-16 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Clinical Diagnostic Solutions |
| Distribution | US |
Product
Boule Con-Diff Tri-Level Multi-Parameter Assayed Hematology Control, used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
Reason
Elevated MCV results on the 1311-682, 1311-683, and 1311-684 lots.
Identifiers
| code_info | Product Part Number: 501-605 Lot# 1311-682 Exp. 3/26/2014 501-607 Lot# 1311-683, 1311-684 Exp. 3/26/2014 501-608 Lot# 1311-683 Exp. 3/26/2014 |
|---|
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-1436-2014%22
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