• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of November 14, 2012

  • Print
  • Share
  • E-mail
-

Event Detail

Event ID 63094
Product Type Devices
Status Ongoing
Recalling Firm Clinical Diagnostic Solutions
City Plantation
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2010-08-04
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Nationwide Distribution.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Boule Con-Diff Hematology Control 9 vials. For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. Product part 501-607, Lot #1005-549 Class III 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 Con-Diff Tri pack Lot 1005-549 were low and out of the assay range. 690 packs Z-0194-2013
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. Product part 501-605, Lot #1005-549 Class III 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 Con-Diff Tri pack Lot 1005-549 were low and out of the assay range. 532 packs Z-0193-2013
-
-