BOX OF COLLECTION KITS, VAGINAL SWAB

Description of Event or Problem

THE CUSTOMER, (B)(6) AT (B)(6), CALLED TO REPORT ONE OF THEIR COLLECTION SITES, (B)(6) HOSPITAL LAB, HAD BEEN USING VAGINAL SWAB COLLECTION KITS TO COLLECT ENDOCERVICAL SPECIMENS. THE SITE HAD DEPLETED THEIR STOCK OF UNISEX SWAB COLLECTION KITS. HOLOGIC TECHNICAL SUPPORT ADVISED THE CUSTOMER THAT THIS IS OFF LABEL AND THAT ONLY THE UNISEX SWAB COLLECTION KIT SHOULD BE USED TO COLLECT ENDOCERVICAL SWAB SPECIMENS. THE SITE RAN OFF PI FOR ABOUT ONE WEEK. THE CUSTOMER TESTED THESE SWAB SPECIMENS WITH THE APTIMA COMBO 2 AND APTIMA TRICHOMONAS VAGINALIS ASSAYS. HOLOGIC EVALUATED THIS ISSUE AND DETERMINED THE RISK TO BE SERIOUS AS AN INCORRECT OR INVALID RESULT DUE TO IMPROPER OR INADEQUATE SAMPLE COLLECTION MAY RESULT IN A DELAY OR FAILURE TO IDENTIFY A CONDITION THAT REQUIRES MEDICAL INTERVENTION. THE CUSTOMER MAY REPORT INCORRECT PATIENT RESULTS AS THE RESULT OF TESTING AN IMPROPER SAMPLE TYPE. ENDOCERVICAL SWAB SPECIMENS COLLECTED USING THE APTIMA VAGINAL SWAB SPECIMEN COLLECTION HAVE NOT BEEN EVALUATED FOR USE WITH THE APTIMA COMBO 2 OR APTIMA TRICHOMONAS VAGINALIS ASSAYS. HOLOGIC TS ADVISED THE CUSTOMER TO USE THE CORRECT TYPE OF SWAB ONLY PER PI.