Hologic Recalls Affirm Lateral Arm Upright Biopsy Accessory Due to Component Issue
Hologic, Inc. is correcting 12 Affirm Lateral Arm Upright Biopsy Accessories in the U.S. due to a component issue that could impact needle alignment during lateral biopsy procedures.
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 product where injury has not yet been reported, meeting the criteria for a High severity score.
Plain-English summary
Hologic, Inc. is implementing a product correction for its Affirm Lateral Arm Upright Biopsy Accessory (Product Number: ASY-09880). The recall involves 12 units distributed in the United States and other locations. The affected devices have UDI Number 15420045506817 and serial numbers LAT1200100 and LAT1200165.
The correction was initiated due to an issue with the Left-hand Guide or Blue Needle Guide component. This defect could impact needle alignment for all left-approach lateral biopsy procedures. Consequently, the position of the needle within the breast may be affected, which could impact the aspiration of the intended tissue. The source notes that this impact is case-dependent and detectable when imaging is used to confirm needle position and tissue acquisition during and after a procedure.
There are no known instances of illness or injury associated with this product correction. The agency classifies this as a Class II recall.
The recalled product
- Product
- Affirm Lateral Arm Upright Biopsy Accessory. Product Number: ASY-09880
- Manufacturer
- Hologic, Inc.
- Affected units
- 12
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)
- UDI Number: 15420045506817 Serial Numbers: LAT1200100 LAT1200165
Distribution
Distribution scope not specified by the agency.
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