Reported May 4, 2016 · Terminated
Hologic InPlex CF Molecular Test (IVD); Catalog Number: 95-432.
Hologic, Inc.
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: Hologic, Inc · 10210 Genetic Center Dr · San Diego, CA · 92121-4362
Is this the product you have?
- Hologic InPlex CF Molecular Test (IVD)
- Catalog Number95-432
- Lot codes and dates
- Lot NumbersC33xx C34xx C35xx (xx denotes sublots)
- Amount recalled
- 2580 total
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Complaints of false positive HET mutations and leaking cards; could lead to unnecessary invasive testing during pregnancy and the associated risks of such invasive testing.
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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