Date Initiated by Firm | July 08, 2013 |
Date Posted | August 28, 2013 |
Recall Status1 |
Terminated 3 on May 01, 2014 |
Recall Number | Z-2111-2013 |
Recall Event ID |
65779 |
PMA Number | P970018S025 |
Product Classification |
Processor, cervical cytology slide, automated - Product Code MKQ
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Product | PrepStain Tecan US-I.
For use in the screening and detection of cervical cancer. |
Code Information |
Catalog Numbers - 799-13000-00 and 799-13000-00R |
Recalling Firm/ Manufacturer |
Becton Dickinson & Co. BD Diagnostic Systems 7 Loveton Circle Sparks MD 21152-0999
|
For Additional Information Contact | Gail Claiborne 410-316-4054 |
Manufacturer Reason for Recall | PrepStain system rack setting was incorrectly entered on one PrepStain system during a routine preventive maintenance visit by a BD Field Service Representative. |
FDA Determined Cause 2 | Software design |
Action | Ex-US BD sites were notified via email and teleconference, and will communicate directly with customer sites in their region as required by local regulation. All US customers were initially contacted via telephone and letters were mailed. |
Quantity in Commerce | 890 instruments |
Distribution | Worldwide Distribution-USA (nationwide) and Puerto Rico and the country of Canada. |
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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