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U.S. Department of Health and Human Services

Class 3 Device Recall PrepStain Syringing Pipettes

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 Class 3 Recall
PrepStain Syringing Pipettes
see related information
Date Posted June 15, 2012
Recall Status1 Terminated on December 03, 2012
Recall Number Z-1811-2012
Recall Event ID 61737
Premarket Approval
PMA Number
P970018
Product Classification Processor, Cervical Cytology Slide, Automated - Product Code MKQ
Product PrepStain Syringing Pipettes 240 (Catalog #490517)
Code Information 100901a, 100902f, 100902f, 100903d, 100908c, 100910c, 100914f, 100916d, 100921d, 100928c, 101005a, 101007d, 101008c, 101012c, 101013a, 101015c, 101020d, 101022c, 101027a, 101028c, 101029d, 101103b, 101105h, 101110f, 101111c, 101117p, 101118n, 101119c, 101130p, 101201o, 101207o, 101208p, 101210c, 101213n, 101214b, 101214c, 101217b, 101220q, 101221g, 110104b, 110106a, 110107c, 110110d, 110112n, 110118b, 110128i, 110203i, 110210r
Recalling Firm/
Manufacturer
Tripath Imaging, Inc.
780 Plantation Dr
Burlington, North Carolina 27215-6723
Consumer Instructions Contact the recalling firm for information
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 CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = MKQ and Applicant = BD DIAGNOSTIC SYSTEMS
PMAs with Product Code = MKQ and Applicant = TRIPATH IMAGING
PMAs with Product Code = MKQ and Applicant = TRIPATH IMAGING, INC.
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