CLASS II Device recall · Reported 24 Jan 2018 · FDA Enforcement Report
Affirm Lateral Arm Upright Biopsy Accessory recalled by Hologic
Hologic is recalling Affirm Lateral Arm Upright Biopsy Accessory. The recall was initiated on 7 Jul 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0351-2018
- FDA event ID
- 78777
- Recalling firm
- Hologic, Danbury, CT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Jul 2017
- FDA classified
- 14 Jan 2018
- Reported
- 24 Jan 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 7 Jul 2017 | Recall initiated by company | |
| 14 Jan 2018 | Classified by FDA | +191 days |
| 24 Jan 2018 | Published in enforcement report | +10 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The firm is implementing a product correction involving its Affirm¿ Lateral Arm Upright Biopsy Accessory, ASY-09880. The correction has been initiated due to a component (the Left-hand Guide or the Blue Needle Guide) issue that could impact needle alignment for all the left-approach lateral biopsy procedures. This may have an impact on the position of the needle within the breast, and thus on the aspiration of the intended tissue. This impact is case-dependent and detectable when imagining is used to confirm needle position and/or tissue acquisition during and after a procedure. There are no known instances of illness or injury.
Product as listed by the FDA
Affirm Lateral Arm Upright Biopsy Accessory. Product Number: ASY-09880
Where it was distributed
US and OUS
Questions about this recall
Is Affirm Lateral Arm Upright Biopsy Accessory recalled?
Yes. Hologic recalled Affirm Lateral Arm Upright Biopsy Accessory on 7 Jul 2017. The recall is Class II and its status is Terminated. Recall number Z-0351-2018.
Why was it recalled?
The firm is implementing a product correction involving its Affirm¿ Lateral Arm Upright Biopsy Accessory, ASY-09880. The correction has been initiated due to a component (the Left-hand Guide or the Blue Needle Guide) issue that could impact needle alignment for all the left-approach lateral biopsy procedures. This may have an impact on the position of the needle within the breast, and thus on the aspiration of the intended tissue. This impact is case-dependent and detectable when imagining is used to confirm needle position and/or tissue acquisition during and after a procedure. There are no known instances of illness or injury.
Which lots are affected?
UDI Number: 15420045506817 Serial Numbers: LAT1200100 LAT1200165
Where was it sold?
US and OUS
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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