Boule Con-Diff Tri-Level Multi-Parameter Assayed Hematology Control — Class II medical device recall Z-1436-2014
Terminated recall by Clinical Diagnostic Solutions, reported 2014-04-16, distributed nationwide. Elevated MCV results on the 1311-682, 1311-683, and 1311-684 lots.
| Recall number | Z-1436-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Clinical Diagnostic Solutions, Plantation, FL, United States |
| Recall initiated | 2013-02-24 |
| Classified | 2014-04-08 |
| Reported by FDA | 2014-04-16 |
| Terminated | 2014-08-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | MX, PH |
| Quantity | 3,540 |
| Lot numbers | 1311-682, 1311-683, 1311-684, 501-607, 501-608 |
| Model numbers | 501-605 |
| Expiration dates | 2014-03-26 |
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 for recall
Elevated MCV results on the 1311-682, 1311-683, and 1311-684 lots.
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-1436-2014. 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.