APTIMA MULTITEST SPECIMEN COLLECTION KIT
Received Jun 15, 2026 · Event occurred May 20, 2026
Report 2024800-2026-00031 · MDR key 25502992
Device
Generic name
Device, Specimen Collection
Manufacturer
Hologic, Inc.Catalog number
ASY-08848
Lot number
925009, 931935
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 (LNS 931935 AND 925009) 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).
Description of Event or Problem
ON (B)(6) 2026, A CUSTOMER REPORTED TO HOLOGIC THAT THE TIP OF MULTIPLE SWABS, INCLUDED IN THE APTIMA MULTITEST SPECIMEN COLLECTION KIT (LNS 931935 AND 925009) DETACHED FROM THE SWABS SHAFT AND REMAINED INSIDE THE PATIENTS DURING SPECIMEN COLLECTION. THE CUSTOMER CONFIRMED THAT MEDICAL ASSISTANCE WAS REQUIRED TO REMOVE THE SWAB TIPS FROM THE PATIENTS. NO FURTHER INFORMATION ON THE PATIENTS¿ STATUS WAS PROVIDED TO HOLOGIC. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE OUTCOMES RELATED TO THIS EVENT.