Boule Con Diff US Tri Pack, 6 Vials. For in vitro diagnostic use as a control to monitor the performance of multi-parame
FDA device recall Z-0193-2013 · posted 2012-11-05 · Terminated
Recall details
- Recalling firm
- Clinical Diagnostic Solutions
- 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
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- JPK
- Quantity affected
- 532 packs
- Distribution
- Nationwide Distribution.
- Date initiated
- 2010-08-04
- Date posted
- 2012-11-05
- Date terminated
- 2014-08-14
- Location
- Plantation, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CDS 3-PD HEMATOLOGY CONTROLS (K024173) | Clinical Diagnostic Solutions, Inc. | 2003-01-14 |