Recall Z-0194-2013 ยท JPK Mixture, Hematology Quality Control
Clinical Diagnostic Solutions
Boule Con-Diff Hematology Control 9 vials. For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
| Date | Nov 5, 2012 (initiated Aug 4, 2010) |
| Status | Terminated |
| 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 |
| Root cause | Process control |
| Action | Clinical Diagnostic Solutions, Inc. sent a "PRODUCT NOTIFICATION:BOULE CON DIFF TRI-LEVEL LOT 1005-549" letter dated August 4, 2010 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. For questions regarding this notice, contact CDS Customer Service at 1-800-453-3328. |
| Quantity | 690 packs |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K024173 | CDS 3-PD HEMATOLOGY CONTROLS Clinical Diagnostic Solutions, Inc., Jan 14, 2003 |