Boule Con-Diff Hematology Control 9 vials — Class III medical device recall Z-0194-2013
Terminated recall by Clinical Diagnostic Solutions, reported 2012-11-14, distributed nationwide. Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled the Boule Con Diff US Tri Pack (Product part 50
| Recall number | Z-0194-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Clinical Diagnostic Solutions, Plantation, FL, United States |
| Recall initiated | 2010-08-04 |
| Classified | 2012-11-05 |
| Reported by FDA | 2012-11-14 |
| Terminated | 2014-08-14 |
| Distributed | Nationwide (US) |
| Quantity | 690 packages |
| Lot numbers | 1005-549 |
| Model numbers | 501-607 |
Product
Boule Con-Diff Hematology Control 9 vials. For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
Reason for recall
Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled the Boule Con Diff US Tri Pack (Product part 501-605, Lot #1005-549 and Product part 501-607, Lot #1005-549) which is used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. The recall was imitated due to receipt of customers stating the MCV values and RDW% recovered for Boule
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-0194-2013. 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.