APTIMA MULTITEST SPECIMEN COLLECTION KIT
Received Jul 22, 2026 · Event occurred Jun 30, 2026
Report 2024800-2026-00048 · MDR key 25906294
Device
Generic name
Device, Specimen Collection
Manufacturer
Hologic, Inc.Catalog number
ASY-08848
Lot number
931499
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: 931499) 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 (PURITAN MEDICAL PRODUCTS COMPANY, LLC). H3 OTHER TEXT : OTHER
Description of Event or Problem
ON (B)(6), 2026, A CUSTOMER FROM NETHERLANDS REPORTED TO HOLOGIC THAT ON (B)(6),2026, THE TIP OF A SWAB, INCLUDED IN THE APTIMA MULTITEST SPECIMEN COLLECTION KIT (LOT NUMBER: 931499) DETACHED FROM THE SWAB SHAFT DURING SPECIMEN COLLECTION. NO FURTHER INFORMATION WAS PROVIDED TO HOLOGIC. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE OUTCOMES RELATED TO THIS EVENT.