Hologic Recalls CF InPlex ASR Cards Due to False Positive Results
Hologic is recalling CF InPlex ASR Cards because they may produce false positive results or leak, potentially leading to unnecessary invasive testing during pregnancy.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of harm (unnecessary invasive testing) where specific injuries or illnesses have not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Hologic, Inc. is recalling 2,580 units of CF InPlex ASR Cards (Catalog Number: 95-0501). The recall involves Lot Numbers U34xx and U35xx, where xx denotes sublots. These products were distributed in 30 U.S. states and Canada.
The recall was initiated due to complaints of false positive HET mutations and leaking cards. The FDA notes that these defects could lead to unnecessary invasive testing during pregnancy, which carries associated risks.
Consumers and healthcare providers should stop using the affected CF InPlex ASR Cards and contact Hologic, Inc. for further instructions or a replacement.
The recalled product
- Product
- CF InPlex ASR Card; Catalog Number: 95-0501.
- Manufacturer
- Hologic, Inc
- Hazard
- 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: U34xx U35xx (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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