Henry Schein 1074050Recalls & reported problems
Henry Schein, Inc. · One Step+ Strep A Dipstick 25 Test · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10304040024147), received between Jun 19, 2019 and Jun 19, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “False Negative Result” (1 report).
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.
Most reported problems
Device problems
- False Negative Result1
Patient problems
- No Code Available1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 19, 2019False Negative Result; False Negative Result
CUSTOMER STATED INITIALLY THAT THERE WAS A NEGATIVE PATIENT OUTCOME, HOWEVER, DID NOT PROVIDE THE OUTCOME. UPON FOLLOWING UP WITH THE CUSTOMER ON 06/11/2019 TO OBTAIN FURTHER CLARIFICATION ON THE NEGATIVE PATIENT OUTCOME, THE CUSTOMER STATED, "AFTER SPEAKING WITH THE DOCTOR THERE WAS NO NEGATIVE OUTCOME, SHE GAVE PATIENT MEDICATION." THERE WAS NO SERIOUS INJURY TO THE PATIENT.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 8712123 ↗
Other ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. devices
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- Acceava® 92001Alere San Diego, Inc. · Antigens, All Groups, Streptococcus Spp.2 recalls2 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
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.