APTIMA MULTITEST SPECIMEN COLLECTION KIT
Received Jul 8, 2026 · Event occurred May 28, 2026
Report 2024800-2026-00041 · MDR key 25749673
Device
Generic name
Device, Specimen Collection
Manufacturer
Hologic, Inc.Catalog number
ASY-08848
Lot number
932841
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: 932841) 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 CUSTOMER FROM NETHERLANDS REPORTED TO HOLOGIC THAT ON (B)(6) 2026, THE TIP OF MULTIPLE SWABS, INCLUDED IN THE APTIMA MULTITEST SPECIMEN COLLECTION KIT (LOT NUMBER: 932841) DETACHED FROM THE SWABS SHAFT DURING ORAL AND RECTAL SPECIMEN COLLECTION. NO FURTHER INFORMATION ON THE PATIENT¿S STATUS WAS PROVIDED TO HOLOGIC. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE OUTCOMES RELATED TO THIS EVENT.