Hologic InPlex CF Molecular Test recall
Hologic InPlex CF Molecular Test (IVD); Catalog Number: 95-432.
Why was Hologic InPlex CF Molecular Test 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers: C33xx C34xx C35xx (xx denotes sublots)
- Product
- Hologic InPlex CF Molecular Test (IVD); Catalog Number: 95-432.
- Recalling firm
- Hologic, Inc
- Quantity
- 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.
- Recall date
- May 4, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)