Recall Z-0194-2013— Clinical Diagnostic Solutions
Class III · Terminated
Class III FDA medical device recall by Clinical Diagnostic Solutions, initiated 2010-08-04, terminated 2014-08-14. It names one FDA 510(k) clearance: K024173. 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: 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.
- Recalling firm
- Clinical Diagnostic Solutions
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2010-08-04
- Terminated
- 2014-08-14
- Firm location
- Plantation, FL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.