Acceava® 92001Recalls & reported problems
Alere San Diego, Inc. · Alere Acceava™ Strep A · Class 1
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10815845020031), received between May 17, 2023 and May 17, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Defective Component” (2 reports).
2 FDA recall records name this device's identifier, 2 still open.
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. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Aug 20, 2024Open, Classified
Due to a classification error in our inventory management system, these medical devices were shipped to customers that did not have the requisite license to purchase such devices.
Z-3185-2024 · Root cause: Process control · FDA record ↗
- May 25, 2022Open, Classified
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
Z-1598-2022 · Root cause: Environmental control · FDA record ↗
Most reported problems
Device problems
- Defective Component2
Patient problems
- Choking1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 17, 2023Defective Component; Defective Component
THE CUSTOMER REPORTED WHILE USING THE ACCEAVA STREP A DIPSTICK AND SWABBING THE PATIENT TO TEST FOR THE PRESENCE OF STREP A, THE TIP OF THE COTTON SWAB FELL OFF. THE CUSTOMER INDICATED THE DETACHED PIECE WENT DOWN THE PATIENT'S THROAT CAUSING THE PATIENT TO CHOKE AND EXPECTORATE SWAB TIP AND IS STABLE. ADDITIONALLY, THE CUSTOMER REPORTEDLY EXAMINED THREE ADDITIONAL COTTON SWABS FROM THE REPORTED KIT, AND FOUR COTTON SWABS EACH FROM THREE ADDITIONAL KITS FROM THE SAME LOT AND NOTED THE COTTON TIPS FROM ALL EXAMINED SWABS FELL OFF AFTER APPLYING GENTLE PRESSURE.
Patient problems: Choking
MAUDE report 16950792 ↗MalfunctionMay 17, 2023Defective Component; Defective Component
THE CUSTOMER REPORTED WHILE EXAMINING THE APPLICATOR WANDS FROM THE ACCEAVA STREP A DIPSTICK KIT, GENTLE PRESSURE WAS APPLIED AND THE COTTON SWAB PORTION OF FOUR APPLICATORS BROKE OFF. VISUAL EXAMINATION OF THE KIT BOXES NOTED NO PHYSICAL OR COSMETIC DAMAGE. THE CUSTOMER REPORTED NO PATIENT HARM OR PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16950750 ↗
Other Antigens, All Groups, Streptococcus Spp. devices
- BD Veritor™ System for Rapid Detection of Group A Strep CLIA-Waived Kit 256040Becton, Dickinson And Company · ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.258 reports
- QuickVue 20108Quidel Corporation · ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.2 recalls0 reports
- Sofia 20274Quidel Corporation · ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.1 recall2 reports
- Clearview® 92002Alere San Diego, Inc. · Antigens, All Groups, Streptococcus Spp.1 recall1 report
- McKesson 5003Mckesson Medical-Surgical Inc. · Antigens, All Groups, Streptococcus Spp.1 recall0 reports
- McKesson 4999Mckesson Medical-Surgical Inc. · Antigens, All Groups, Streptococcus Spp.1 recall0 reports
- QuickVue In-Line 00345Quidel Corporation · ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.1 recall0 reports
- QuickVue 20125Quidel Corporation · ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.