Recall Z-0190-2013 ยท JPK Mixture, Hematology Quality Control
Clinical Diagnostic Solutions
Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
| Date | Nov 2, 2012 (initiated Mar 24, 2011) |
| Status | Terminated |
| 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 |
| Root cause | Nonconforming Material/Component |
| Action | Clinical Diagnostic Solutions, Inc. sent a letter dated March 24, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The firm istructed the accounts to replace the assay sheet they were currently using with the new assay sheets enclosed. For an unused product they would need to discard. To correct the ranges in their instrument, they would need to scan in the new bar codes specific for their instrument type. For any questions customers were instructed to contact CDE Technical Support atl 800-453-3328. For questions |
| Quantity | 901 vials |
| Distribution | Worldwide Distribution - USA including AL, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MS, ND, ND, NE, NJ, NY, OH, OK, PA, SC, TN, TX, UT, VA, WI, WV,and WY. Foreign: Brazil and Colombia |
| 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 |