FDA Device recall Z-0189-2013
Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instrum…
- FDA Device
- Class III
- terminated
- Published 2012-11-14
On 2012-11-14 the FDA classified a Class III recall of Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instrum… by Clinical Diagnostic Solutions, citing clinical Diagnostic Solutions, Inc. in Plantation, FL recalled Boule Con Diff US Tri Pack (Product Part 501-605, Lot #1102-575 and 1102-576; Product Part 501-607, Lot #1102-576; a….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0189-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2011-03-24 |
| Published | 2012-11-14 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Clinical Diagnostic Solutions |
| Distribution | AL, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MS, ND, NE, NJ, NY, OH, OK, PA, SC, TN, TX, UT, VA, WI, WV, WY |
Product
Boule Con-Diff Hematology Control 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 Boule Con Diff US Tri Pack (Product Part 501-605, Lot #1102-575 and 1102-576; Product Part 501-607, Lot #1102-576; and Product Part 502-012, Lot #1102-574) which is used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. The recall was initiated due to the receipt of a complai
Identifiers
| code_info | Product Part 501-605, Lot #1102-575 and Lot # 1102-576 |
|---|
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-0189-2013%22
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