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
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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 |
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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.
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PMA Database | PMAs with Product Code = MKQ
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