FDA Device recall Z-0193-2013
Boule Con Diff US Tri Pack, 6 Vials
- FDA Device
- Class III
- terminated
- Published 2012-11-14
On 2012-11-14 the FDA classified a Class III recall of Boule Con Diff US Tri Pack, 6 Vials by Clinical Diagnostic Solutions, citing 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 i….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0193-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2010-08-04 |
| Published | 2012-11-14 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Clinical Diagnostic Solutions |
| Distribution | US |
Product
Boule Con Diff US Tri Pack, 6 Vials. For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
Reason
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
Identifiers
| code_info | Product part 501-605, Lot #1005-549 |
|---|
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-0193-2013%22
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