Hologic InPlex CF Molecular Test (IVD); Catalog Number: 95-432.
Reported: May 4, 2016 Initiated: March 31, 2016 #Z-1580-2016
Product Description
Hologic InPlex CF Molecular Test (IVD); Catalog Number: 95-432.
Reason for Recall
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.
Details
- Recalling Firm
- Hologic, Inc
- Units Affected
- 2580 total
- Distribution
- Distributed in the states of OH, AL, IL, AZ, AR, NJ, TX, GA, CO, DE, NC, MI, FL, ME, CA, IN, OR, KS, KY, MO, WA, NY, OK, WV, CT, IA, LA, RI, MA, and PA, and in the country of Canada.
- Location
- San Diego, CA
Frequently Asked Questions
What product was recalled? ▼
Hologic InPlex CF Molecular Test (IVD); Catalog Number: 95-432.. Recalled by Hologic, Inc. Units affected: 2580 total.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 4, 2016. Severity: Moderate. Recall number: Z-1580-2016.
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