Reported Sep 4, 2013 · Terminated
PrepStain AG. For use in the screening and detection of cervical cancer.
Becton Dickinson & Co.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Becton Dickinson & Co. · BD Diagnostic Systems · Sparks, MD · 21152-0999
Is this the product you have?
- PrepStain AG. For use in the screening and detection of cervical cancer.
- Lot codes and dates
Catalog Numbers - 05CR0002105CR00021R05CR0002205CR00022R05CR0002305CR00023R
- Amount recalled
- 890 instruments
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
PrepStain system rack setting was incorrectly entered on one PrepStain system during a routine preventive maintenance visit by a BD Field Service Representative.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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