Recall Z-0351-2018 ยท OIJ Biopsy Needle Guide Kit
Hologic, Inc.
Affirm Lateral Arm Upright Biopsy Accessory. Product Number: ASY-09880
| Date | Jul 7, 2017 |
| Status | Terminated |
| Reason | 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 kn |
| Root cause | Component change control |
| Action | Letter |
| Quantity | 12 (U.S.) |
| Distribution | US and OUS |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161575 | Affirm Lateral Arm Upright Biopsy Accessory Hologic, Aug 10, 2016 |