APTIMA MULTITEST SPECIMEN COLLECTION KIT
Received Oct 27, 2025 · Event occurred Oct 2, 2025
Report 2024800-2025-00069 · MDR key 23393155
Device
Generic name
Device, Specimen Collection
Manufacturer
Hologic, Inc.Catalog number
ASY-08848
Lot number
922935
Product problems
- Material Separation
- Material Separation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ON (B)(6) 2025, CUSTOMER REPORTED TO HOLOGIC THAT THEY HAD AN APTIMA MULTITEST SWAB SPECIMEN COLLECTION KIT (LN 922935) BOX THAT CONTAINED SWABS WITH TIPS THAT WERE DETACHING FROM THE STICK. CUSTOMER REPORTED THEY WERE UNABLE TO USE THE SWABS IN THE KIT BOX. NO INJURIES WERE REPORTED AS A RESULT OF THIS EVENT, AND NO PATIENTS WERE AFFECTED AS THE SWABS WERE UNUSED. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE OUTCOMES RELATED TO THIS EVENT.
Additional Manufacturer Narrative
HOLOGIC ATTEMPTED TO REACH OUT TO THE CUSTOMER FOR MORE INFORMATION ON THE SWAB LOT BUT CUSTOMER WAS NOT ABLE TO PROVIDE ADDITIONAL INFORMATION. HOLOGIC EVALUATED RETENTION MATERIALS FROM THIS LOT LN 922935 BUT WAS NOT ABLE TO REPLICATE THE CUSTOMER ISSUE. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE OUTCOMES RELATED TO THIS ISSUE. H3 OTHER TEXT: OTHER.