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U.S. Department of Health and Human Services

Class 3 Device Recall Manual Method 1: 480 Test Kit (PreCoat)

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  Class 3 Device Recall Manual Method 1: 480 Test Kit (PreCoat) see related information
Date Initiated by Firm March 22, 2012
Date Posted June 15, 2012
Recall Status1 Terminated 3 on December 03, 2012
Recall Number Z-1814-2012
Recall Event ID 61737
PMA Number P970018 
Product Classification Processor, cervical cytology slide, automated - Product Code MKQ
Product Manual Method 1: 480 Test Kit (PreCoat), Catalog/Model # 490529
Code Information 100903ru, 100924rr, 101022sc, 110114sh, 110225ru
Recalling Firm/
Manufacturer		 Tripath Imaging, Inc.
780 Plantation Dr
Burlington NC 27215-6723
For Additional Information Contact
336-222-9707
Manufacturer Reason
for Recall		 The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. This event resulted in an increase in complaints of leaking syringing pipettes
FDA Determined
Cause 2		 Component design/selection
Action BD Diagnostics sent a "BD PrepMate Syringing Pipette" letter dated March 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The firm encouraged customers to refer to the Operator's Manual and inspect the centrifuge tubes to verify that the correct amount of sample has been transferred. Customers experiencing this issue were instructed to discard the pipettes and contact BD Diagnostic Technical Support for a replacement. Contact the firm at 1-877-822-7771 for questions regarding this notice.
Quantity in Commerce 46,112,784 for all products in Recall Event
Distribution Worldwide 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = MKQ and Original Applicant = BD Diagnostic Systems
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