BD Affirm™ VPIII Ambient Temperature Transport System 446255Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 30382904462551), received between Dec 28, 2017 and Feb 6, 2026 — classified as 11 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Product Quality Problem” (6 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2026Break

  IT WAS REPORTED THAT UPON USE OF BD AFFIRM¿ ATTS, DURING SWABBING FOR SPECIMEN COLLECTION, THE SWAB TIP BECAME SEPARATED FROM THE SHAFT. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24282868 ↗
• MalfunctionJul 22, 2025Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT UPON USE OF THE BD AFFIRM ATTS, AN EMPLOYEE AT A DOCTOR OFFICE FAILED TO PROPERLY BREAK THE AMPULE AND TRANSFER THE PATIENT SAMPLE. THE ENTIRE AMPULE WAS INCORRECTLY TRANSFERRED INTO THE TRANSPORTATION TUBE, SO WHEN PROCESSING, OPERATOR WAS PRICKED BY AMPULE GLASS. THE PATIENT WAS POSITIVE FOR UNKNOWN ORGANISM. SUPERVISOR SENT INJURED OPERATOR TO BE SEEN BY A MEDICAL PROFESSIONAL IN THEIR FACILITY RIGHT AWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22569425 ↗
• MalfunctionNov 30, 2023Product Quality Problem; Product Quality Problem

  IT HAS BEEN REPORTED THAT THE KIT AFFIRM ATT SYSTEM 100 EA HAS BEEN FOUND WITH THE AMPULE PUNCTURING SKIN DURING USE. NO SERIOUS INJURY WAS REPORTED, FIRST AIDE PROVIDED. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: AFF 446255 INJURY WHEN BREAKING THE AMPULE. CUSTOMER REPORTS AN INJURY WHEN BREAKING THE AMPULE: A SMALL PINPOINT BREAK IN SKIN. FIRST AIDE PROVIDED (CLEANSED AND BAND AID APPLIED); NO FURTHER TREATMENT REQUIRED.

  Patient problems: Abrasion

  MAUDE report 18243294 ↗
• InjuryOct 12, 2023Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT WHILE USING KIT AFFIRM ATT SYSTEM 100 EA THAT THERE WAS AN ATTS AMPULE SKIN PUNCTURE- WITH PATIENT SAMPLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS CUSTOMER REPORTS REAGENT HAS CUT STAFF WHILE USING. CAREGIVER INJURED WHILE OPENING THE AFFIRM ATTS VIAL WITHOUT USE OF THE PROVIDED AMPULE OPENER. THE GLASS AMPULE BROKE THRU THE PLASTIC, CUTTING THE CAREGIVER'S GLOVED FINGER. THE CAREGIVER WAS SENT TO THE ER FOR FOLLOW-UP DUE TO CONCERNS THAT SHE MAY HAVE COME IN CONTACT WITH THE PATIENT SAMPLE SWAB VIA THE CUT SUSTAINED FROM THE BROKEN GLASS. CUSTOMER PROBLEM: CUSTOMER IS REPORTING REAGENT HAS CUT STAFF WHILE USING. AFFECTED LOT NUMBER B02F016M.

  Patient problems: Laceration(s)

  MAUDE report 17925863 ↗
• InjuryMay 24, 2023Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT KIT AFFIRM ATT SYSTEM 100 EA CAREGIVER WAS CUT BY SHARP MATERIAL WITH EXPOSURE TO PATIENT FLUID THROUGH CUT IN GLOVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CAREGIVER CUT BY SHARP MATERIAL AFTER BREAKING AMPULE WITH EXPOSURE TO PATIENT BODY FLUID THROUGH CUT IN GLOVE. ALSO HAD SECOND SEPARATE INSTANCE OF CAREGIVER BEING CUT WHEN OPENING AMPULE, BUT WITHOUT EXPOSURE TO BODY FLUID.

  Patient problems: Exposure to Body Fluids

  MAUDE report 16994730 ↗
• InjuryMay 12, 2023Product Quality Problem; Product Quality Problem

  THIS REPORT IS FOR PATIENT 2 OF 2. IT WAS REPORTED THAT WHILE USING THE KIT AFFIRM ATT SYSTEM 100 EA THAT TWO LAB TECHS SUSTAINED MINOR CUTS ON THEIR FOREFINGER FROM A SHARD OF GLASS WHEN SQUEEZING THE ATTS PLASTIC VIAL TO BREAK THE GLASS AMPULE INSIDE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES THAT TWO TECHS SUSTAINED MINOR CUTS ON THEIR FOREFINGER FROM A SHARD OF GLASS WHEN SQUEEZING THE ATTS PLASTIC VIAL TO BREAK THE GLASS AMPULE INSIDE. (SMALL PIECE OF GLASS PROTRUDED FROM THE PLASTIC VIAL IN EACH INSTANCE). THE FIRST OCCURRENCE WAS ON 4/12/23 AND THE OTHER OCCURRENCE WAS A FEW DAYS PRIOR (DIFFERENT TECH). THERE WAS NO PATIENT SPECIMEN INVOLVED (OCCURRENCE PRIOR TO SAMPLE COLLECTION). NEITHER TECH REQUIRED MEDICAL TREATMENT OR HAD ANY OTHER ILL EFFECTS AFTER THE INCIDENT. LOT#-NOT AVAILABLE CASE CONTACT CONFIRMED THAT NEITHER TECH USED THE GREEN ATTS DISPENSING TOOL/AMPULE OPENER INCLUDED WITH THE BOX OF 10 ATTS REAGENT VIALS. NEXT STEPS (IF NECESSARY): THE CUSTOMER WILL REVIEW WITH THE TECHS THE IMPORTANCE OF USING THE ATTS DISPENSING TOOL TO PREVENT FUTURE INJURIES FROM OCCURRING. CUSTOMER IS ALSO REQUESTING ADDITIONAL ATTS DISPENSING TOO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16924415 ↗
• InjuryMay 11, 2023Product Quality Problem; Product Quality Problem

  THIS REPORT IS FOR PATIENT 1 OF 2. IT WAS REPORTED THAT WHILE USING THE KIT AFFIRM ATT SYSTEM 100 EA THAT TWO LAB TECHS SUSTAINED MINOR CUTS ON THEIR FOREFINGER FROM A SHARD OF GLASS WHEN SQUEEZING THE ATTS PLASTIC VIAL TO BREAK THE GLASS AMPULE INSIDE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES THAT TWO TECHS SUSTAINED MINOR CUTS ON THEIR FOREFINGER FROM A SHARD OF GLASS WHEN SQUEEZING THE ATTS PLASTIC VIAL TO BREAK THE GLASS AMPULE INSIDE. (SMALL PIECE OF GLASS PROTRUDED FROM THE PLASTIC VIAL IN EACH INSTANCE). THE FIRST OCCURRENCE WAS ON 4/12/23 AND THE OTHER OCCURRENCE WAS A FEW DAYS PRIOR (DIFFERENT TECH). THERE WAS NO PATIENT SPECIMEN INVOLVED (OCCURRENCE PRIOR TO SAMPLE COLLECTION). NEITHER TECH REQUIRED MEDICAL TREATMENT OR HAD ANY OTHER ILL EFFECTS AFTER THE INCIDENT. LOT#-NOT AVAILABLE CASE CONTACT CONFIRMED THAT NEITHER TECH USED THE GREEN ATTS DISPENSING TOOL/AMPULE OPENER INCLUDED WITH THE BOX OF 10 ATTS REAGENT VIALS. NEXT STEPS (IF NECESSARY): THE CUSTOMER WILL REVIEW WITH THE TECHS THE IMPORTANCE OF USING THE ATTS DISPENSING TOOL TO PREVENT FUTURE INJURIES FROM OCCURRING. CUSTOMER IS ALSO REQUESTING ADDITIONAL ATTS DISPENSING TOO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16916037 ↗
• MalfunctionMar 24, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING KIT AFFIRM ATT SYSTEM 100 EA THE REAGENT SPLASHED IN THE EYE OF THE LABORATORY PERSONNEL. THE CUSTOMER STATED THERE WAS NO IMPACT TO THE LABORATORY PERSONNEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11565988 ↗
• MalfunctionMar 24, 2021Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT WHILE USING KIT AFFIRM ATT SYSTEM 100 EA THE LABORATORY PERSONNEL HAD THEIR SKIN PUNCTURED WHILE BREAKING AN AMPULE WITH NO PATIENT SAMPLE. FIRST AID WAS APPLIED AND THERE WAS NO OTHER IMPACT REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11565891 ↗
• InjuryFeb 15, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED WHEN OPENING A KIT AFFIRM ATT SYSTEM THE AMPULE BROKE EXPOSING THE PATIENT TO THE CONTENTS. THE PATIENT SPAT IT OUT AND RINSED THEIR MOUTH WITH WATER. THERE IS NO REPORT OF FURTHER ISSUE. "CUSTOMER PROBLEM: ATTS VIAL CONTENTS ACCIDENTALLY GOT IN THE PATIENT'S MONTH THE LIQUID GOT IN PATIENT'S MOUTH, SHE SPAT IT OUT IMMEDIATELY, AND RINSED HER MOUTH WITH WATER. CUSTOMER DOES NOT HAVE ANY INJURIES AND FEELS FINE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11327874 ↗
• MalfunctionJan 29, 2021Break; Break

  IT WAS REPORTED THAT WHILE USING KIT AFFIRM ATT SYSTEM 100 EA THE TIP OF THE SWAB BROKE OFF INSIDE THE PATIENT. THIS COULD LEAD TO SERIOUS INJURY AND NECESSITATE MEDICAL INTERVENTION. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11254338 ↗
• MalfunctionJan 8, 2021Break

  IT WAS REPORTED WHILE USING BD AFFIRM¿ VPIII AMBIENT TEMPERATURE TRANSPORT SYSTEM THE SWAB TIP BROKE OFF IN PATIENT'S VAGINA. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11143150 ↗
• InjuryMay 7, 2019Break

  THIS REPORT REPRESENTS PATIENT 2 OF 2: IT WAS REPORTED WHILE USING A BD AFFIRM¿ VPIII AMBIENT TEMPERATURE TRANSPORT SYSTEM, THE LAB TECHNICIAN BROKE THE GLASS AMPULE WITH A REAGENT DROPPER. HOWEVER, AFTER BREAKING THE GLASS AMPULE, THE LAB TECHNICIAN REMOVED THE CAP AND POURED THE CONTENTS INTO A SAMPLE COLLECTION TUBE. THE TECHNICIAN DID NOT NOTICE THE GLASS SHARDS IN THE TUBE AND CUT THEIR FINGERS WHILE SQUEEZING THE COLLECTION TUBE. THE LAB TECHNICIAN WAS EXPOSED TO PATIENT SAMPLE THROUGH THE CUTS IN THEIR FINGERS. THE LAB TECHNICIAN WAS TREATED WITH FIRST AID ON SITE WHICH INCLUDED RINSING THE INJURY SITE AND BANDAGING THEIR WOUNDS. POST EXPOSURE, THE LAB TECHNICIAN WAS TESTED AND THEN MONITORED FOR HIV AND HEPATITIS. NO INDICATION WAS GIVEN THAT THE PATIENT HAD CONTRACTED A BLOOD BOURNE ILLNESS FROM THE EXPOSURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS TWO INJURIES DUE TO THE GLASS AMPULE IN THE ATTS KIT. THE CUSTOMER STATES THEY WERE RECEIVING SAMPLES FROM COLLECTION SITES WHERE THE COLLECTION SITES HAVE CORRECTLY BROKEN THE GLASS AMPULE USING THE REAGENT DROPPER BUT HAVE REMOVED THE CAP AND POURED THE CONTENTS INTO THE TRANSPORT/SAMP

  Patient problems: Exposure to Body Fluids; Injury

  MAUDE report 8588897 ↗
• InjuryMay 7, 2019Break

  THIS REPORT REPRESENTS PATIENT 1 OF 2: IT WAS REPORTED WHILE USING A BD AFFIRM¿ VPIII AMBIENT TEMPERATURE TRANSPORT SYSTEM THE LAB TECHNICIAN BROKE THE GLASS AMPULE WITH A REAGENT DROPPER. HOWEVER, AFTER BREAKING THE GLASS AMPULE THE LAB TECHNICIAN REMOVED THE CAP AND POURED THE CONTENTS INTO A SAMPLE COLLECTION TUBE. THE TECHNICIAN DID NOT NOTICE THE GLASS SHARDS IN THE TUBE AND CUT THEIR FINGERS WHILE SQUEEZING THE COLLECTION TUBE. THE LAB TECHNICIAN WAS EXPOSED TO PATIENT SAMPLE THROUGH THE CUTS IN THEIR FINGERS. THE LAB TECHNICIAN WAS TREATED WITH FIRST AID ON SITE WHICH INCLUDED RINSING THE INJURY SITE AND BANDAGING THEIR WOUNDS. POST EXPOSURE, THE LAB TECHNICIAN WAS TESTED AND THEN MONITORED FOR (B)(6). NO INDICATION WAS GIVEN THAT THE PATIENT HAD CONTRACTED A BLOODBORNE ILLNESS FROM THE EXPOSURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS TWO INJURIES DUE TO THE GLASS AMPULE IN THE ATTS KIT. THE CUSTOMER STATES THEY WERE RECEIVING SAMPLES FROM COLLECTION SITES WHERE THE COLLECTION SITES HAVE CORRECTLY BROKEN THE GLASS AMPULE USING THE REAGENT DROPPER BUT HAVE REMOVED THE CAP AND POURED THE CONTENTS INTO THE TRANSPORT/SAMPLE COLLECTION T

  Patient problems: Exposure to Body Fluids; Injury

  MAUDE report 8588895 ↗
• InjuryOct 9, 2018Material Protrusion/Extrusion

  IT WAS REPORTED THAT WHILE USING A BD AFFIRM¿ VPIII AMBIENT TEMPERATURE TRANSPORT SYSTEM THE TECHNICIAN WAS PLACING THE SAMPLE TUBE INTO THE DEVICE WHEN SHARP PIECES OF THE GLASS AMPULE PENETRATED THE WALL OF THE DEVICE AND CUT THE FINGER OF THE TECHNICIAN RESULTING IN EXPOSURE TO PATIENT SAMPLE. THE TECHNICIAN RECEIVED A MEDICAL EVALUATION AND WAS TREATED FOR EXPOSURE TO BLOODBORNE PATHOGENS AT AN URGENT CARE FACILITY.

  Patient problems: Exposure to Body Fluids; Laceration(s)

  MAUDE report 7946720 ↗
• InjuryMar 2, 2018Insufficient Device Problem Information

  IT WAS REPORTED THAT A TECHNICIAN CUT THEIR FINGER WHILE USING A BD AFFIRM¿ VPIII AMBIENT TEMPERATURE TRANSPORT SYSTEM EXPOSING THEM TO BODILY FLUIDS. INJURY AND MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: Injury; No Code Available

  MAUDE report 7311692 ↗
• InjuryJan 11, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECHNICIAN EXPERIENCED A PUNCTURE FROM GLASS FROM A BD AFFIRM¿ VPIII AMBIENT TEMPERATURE TRANSPORT SYSTEM DURING THE FILTERING STEP OF THE PROCESS.

  Patient problems: Needle Stick/Puncture

  MAUDE report 7183459 ↗
• InjuryDec 28, 2017Insufficient Device Problem Information

  IT WAS REPORTED THAT A CLINICIAN RECEIVED A CUT WITH POTENTIAL EXPOSURE TO BODILY FLUIDS WHEN USING A BD AFFIRM¿ VPIII AMBIENT TEMPERATURE TRANSPORT SYSTEM. TECHNICIAN INJURED FINGER AND REQUIRED FIRST AID.

  Patient problems: Laceration(s)

  MAUDE report 7151414 ↗