APTIMA SWAB SPECIMEN COLLECTION KIT
Received Oct 15, 2015 · Event occurred Sep 23, 2015
Report 2024800-2015-00004 · MDR key 5154616
Device
Generic name
In-vitro Diagnostic Assay
Manufacturer
Hologic, Inc.Model number
301041-01Catalog number
301041-01
Lot number
108901A
Product problems
- Manufacturing, Packaging or Shipping Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
A CUSTOMER FOUND AN IMPROVISED CUTTING DEVICE CONTAINED IN ONE OF THE COLLECTION POUCHES IN AN APTIMA SWAB COLLECTION KIT, P/N 301041-01, L/N 108901. THERMOFORMER OPERATORS ARE REQUIRED TO CUT PAPER AND PLASTIC ROLLS AND THIS DEVICE MUST HAVE BEEN USED BY AN OPERATOR FOR THIS PURPOSE. THIS DEVICE MUST HAVE ACCIDENTLY FELL INTO A POUCH DURING THE MANUFACTURING PROCESS. THERE HAVE BEEN NO FURTHER COMPLAINTS BY CUSTOMERS FOR THIS LOT OF COLLECTION KITS. THIS INVESTIGATION CONCLUDES THAT IT IS HIGHLY UNLIKELY THAT ANY MORE OF THESE DEVICES ARE IN POUCHES FROM THIS BATCH.