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U.S. Department of Health and Human Services

Class 3 Device Recall Boule ConDiff Hematology Control

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 Class 3 Device Recall Boule ConDiff Hematology Controlsee related information
Date Initiated by FirmAugust 04, 2010
Date PostedNovember 05, 2012
Recall Status1 Terminated 3 on August 14, 2014
Recall NumberZ-0193-2013
Recall Event ID 63094
510(K)NumberK024173 
Product Classification Mixture, hematology quality control - Product Code JPK
ProductBoule Con Diff US Tri Pack, 6 Vials. For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
Code Information Product part 501-605, Lot #1005-549  
Recalling Firm/
Manufacturer		 Clinical Diagnostic Solutions
1800 Nw 65th Ave Ste 2
Plantation FL 33313-4544
For Additional Information ContactMaritza Pastoriza
954-791-1773
Manufacturer 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 2		Process control
ActionClinical 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.
Quantity in Commerce532 packs
DistributionNationwide Distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JPK
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