Recall Z-0194-2013
Clinical Diagnostic Solutions · initiated August 4, 2010
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
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.
Codes / lots: Product part 501-607, Lot #1005-549
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
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-0194-2013
- Initiated
- August 4, 2010
- Posted by FDA
- November 5, 2012
- Terminated
- August 14, 2014
- Product code
- JPK – Mixture, Hematology Quality Control
- Quantity
- 690 packs
- Distribution
- Nationwide Distribution.
- Recalling firm
- Clinical Diagnostic Solutions, Plantation, FL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0193-2013 Class III | Boule Con Diff US Tri Pack, 6 Vials. For in vitro diagnostic use as a control to monitor…Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled the Boule Con Diff US Tri Pack (Product part… | 08/04/2010Terminated |