APTIMA MULTITEST SPECIMEN COLLECTION KIT
Received Jun 23, 2026 · Event occurred Jun 4, 2026
Report 2024800-2026-00037 · MDR key 25595231
Device
Generic name
Device, Specimen Collection
Manufacturer
Hologic, Inc.Catalog number
ASY-08848
Lot number
933932
Product problems
- Material Separation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A REVIEW OF THE PART HISTORY FILE ASSOCIATED WITH THE MULTITEST SWABS INCLUDED IN THE APTIMA MULTITEST SWAB KIT (LN: 933932) CONFIRMED THAT THE SWABS SUCCESSFULLY PASSED INSPECTION SPECIFICATIONS. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE OUTCOMES RELATED TO THIS ISSUE. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) HAS BEEN ISSUED TO THE SUPPLIER OF THE SWABS ((B)(4)). H3 OTHER TEXT: OTHER.
Description of Event or Problem
ON (B)(6) 2026, A CANADIAN CUSTOMER REPORTED TO HOLOGIC THAT DURING RECTAL SPECIMEN COLLECTION WITH THE APTIMA MULTITEST SPECIMEN COLLECTION KIT (LN 933932), A PORTION OF THE SWAB TIP FIBERS REMAINED INSIDE THE PATIENT AND HAD TO BE PHYSICALLY REMOVED. NO FURTHER INFORMATION ON THE PATIENT¿S STATUS AFTER LEAVING THE CLINIC WAS PROVIDED TO HOLOGIC. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE OUTCOMES RELATED TO THIS EVENT.