MalfunctionLIO
APTIMA MULTITEST SPECIMEN COLLECTION KIT
Received Jun 15, 2026 · Event occurred May 20, 2026
Report 2024800-2026-00032 · MDR key 25503550
Device
Product problems
- Material Separation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
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).
Description of Event or Problem
ON (B)(6) 2026, A CUSTOMER REPORTED TO HOLOGIC THAT THEY HAD AN APTIMA MULTITEST SWAB SPECIMEN COLLECTION KIT THAT CONTAINED SWABS MISSING THE TIP OR WITH DEFECTIVE SWABS. CUSTOMER DID NOT PROVIDE THE LOT OF THE APTIMA MULTITEST SWAB SPECIMEN COLLECTION KIT. NO INJURIES WERE REPORTED AS A RESULT OF THIS EVENT. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE OUTCOMES RELATED TO THIS EVENT.