Hologic InPlex CF Molecular Test Recalled for False Positives and Leaking
Hologic is recalling InPlex CF Molecular Tests due to false positive results and leaking cards, which could lead to unnecessary invasive testing during pregnancy.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of unnecessary invasive testing during pregnancy, which aligns with the rubric criteria for Severe severity (FDA Class II with significant injury/property-damage reports or high-risk scenarios).
Plain-English summary
Hologic, Inc. is recalling 2,580 units of the Hologic InPlex CF Molecular Test (IVD), Catalog Number 95-432. The recall affects Lot Numbers C33xx, C34xx, and C35xx, where xx denotes sublots. These products were 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, as well as in Canada.
The recall was initiated due to complaints of false positive HET mutations and leaking cards. The FDA classifies this as a Class II recall. The false positive results could lead to unnecessary invasive testing during pregnancy, exposing patients to the associated risks of such procedures.
Healthcare providers and consumers should stop using the affected products and contact Hologic, Inc. for further instructions or a replacement.
The recalled product
- Product
- Hologic InPlex CF Molecular Test (IVD); Catalog Number: 95-432.
- Manufacturer
- Hologic, Inc
- Affected units
- 2,580
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Numbers: C33xx C34xx C35xx (xx denotes sublots)
Distribution
Part of a larger recall action
This product is one of 2 recalled by Hologic, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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