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U.S. Department of Health and Human Services

Class 2 Device Recall CytoChex BCT

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  Class 2 Device Recall CytoChex BCT see related information
Date Initiated by Firm February 23, 2017
Date Posted March 08, 2017
Recall Status1 Open3, Classified
Recall Number Z-1684-2017
Recall Event ID 76501
510(K)Number K080552  
Product Classification Tubes, vacuum sample, with anticoagulant - Product Code GIM
Product Cyto-Chex BCT - blood specimen collection device - Immunophenotyping Preservative. IVD. Sterile. 2.0ml only. Packaged 6-tube pack REF 213559 and 100-tube box REF 218980. Streck.
Code Information UDI Number 10844509000836 and 20844509000833.  Lot(s) Expiration Date 50910309 04-01-2017 60760309 03-16-2018 61460309 05-25-2018 
Recalling Firm/
Manufacturer		 Streck
7002 S 109th St
La Vista NE 68128-5729
For Additional Information Contact Maria J. Dosseh
402-333-1982
Manufacturer Reason
for Recall		 Complaints of the 2.0ml tube stopper coming loose during phlebotomy when small diameter tube adapters were not utilized. Such adapters aid with centering small diameter tubes to properly pierce the middle of the stoppers.
FDA Determined
Cause 2		 Error in labeling
Action On February 23, 2017, Streck electronically notified customers of the updated device correction. The recalling firm used an electronic mail alert to notify all of their customers the IFU for the recalled product had been revised. The specified the revision included phlebotomy guidelines specific to the 2.0 ml blood collections tubes. The revised IFU was provided as a link in the email. The recalling firm is reportedly able to monitor the access of the revised IFU to ensure each customer has received the information. For further questions, please call (402) 333-1982.
Quantity in Commerce 128,692 tubes
Distribution Worldwide Distribution - USA (nationwide) and to the countries of : Belgium, Canada, Germany, Israel, Japan, the Republic of Korea, the Netherlands, and the United Kingdom. There was no military or government distribution.
Total Product Life Cycle TPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = GIM and Original Applicant = Streck
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