Recall Z-0189-2013
Clinical Diagnostic Solutions · initiated March 24, 2011
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
Codes / lots: Product Part 501-605, Lot #1102-575 and Lot # 1102-576
Reason for recall
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
FDA-determined cause: Nonconforming Material/Component
Action taken
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 regarding this recall call 954-791-1773.
Details
- Recall number
- Z-0189-2013
- Initiated
- March 24, 2011
- Posted by FDA
- November 2, 2012
- Terminated
- August 13, 2014
- Product code
- JPK – Mixture, Hematology Quality Control
- Quantity
- 623 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
- Recalling firm
- Clinical Diagnostic Solutions, Plantation, FL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0190-2013 Class III | Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor…Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled Boule Con Diff US Tri Pack (Product Part… | 03/24/2011Terminated |
| Z-0191-2013 Class III | Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor…Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled Boule Con Diff US Tri Pack (Product Part… | 03/24/2011Terminated |