FDA Enforcement
Class III
Terminated
Boule Con Diff US Tri Pack, 6 Vials. For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
Recall: Z-0193-2013
·
Reported November 14, 2012
Enforcement
- Recall Number
- Z-0193-2013
- Event ID
- 63094
- Classification
- Class III
- Status
- Terminated
- Product Type
- Devices
- Firm
- Clinical Diagnostic Solutions
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 14, 2012
- Initiation Date
- August 4, 2010
- Classification Date
- November 5, 2012
- Termination Date
- August 14, 2014
- Address
- 1800 Nw 65th Ave Ste 2, N/A, Plantation, FL, 33313-4544, United States
Description
Boule Con Diff US Tri Pack, 6 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
Code Info
Product part 501-605, Lot #1005-549
Distribution
Nationwide Distribution.
Quantity
532 packs