PrepStain Tecan US-II. For use in the screening and detection of cervical cancer.
Reported: September 4, 2013 Initiated: July 8, 2013 #Z-2112-2013
Product Description
PrepStain Tecan US-II. For use in the screening and detection of cervical cancer.
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.
Details
- Recalling Firm
- Becton Dickinson & Co.
- Units Affected
- 890 instruments
- Distribution
- Worldwide Distribution-USA (nationwide) and Puerto Rico and the country of Canada.
- Location
- Sparks, MD
Frequently Asked Questions
What product was recalled? ▼
PrepStain Tecan US-II. For use in the screening and detection of cervical cancer.. Recalled by Becton Dickinson & Co.. Units affected: 890 instruments.
Why was this product recalled? ▼
PrepStain system rack setting was incorrectly entered on one PrepStain system during a routine preventive maintenance visit by a BD Field Service Representative.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 4, 2013. Severity: Moderate. Recall number: Z-2112-2013.
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