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U.S. Department of Health and Human Services

Enforcement Report - Week of November 14, 2012

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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 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
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
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