Clearview PBP2a SA Culture Colony Test 893-000Recalls & reported problems
Alere Scarborough, Inc. · A rapid test for the qualitative detection of PBP2a in Staphylococcus aureus isolates. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10811877011238), received between Aug 17, 2023 and Aug 17, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (2 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
Device problems
- Improper or Incorrect Procedure or Method2
- Leak/Splash2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 17, 2023Leak/Splash; Improper or Incorrect Procedure or Method; Leak/Splash; Improper or Incorrect Procedure or Method
THE CUSTOMER REPORTED TWO (2) REAGENT AND SAMPLE EXPOSURE TO THE SKIN WITH THE CLEARVIEW PBP2A SA CULTURE COLONY TEST PERFORMED ON (B)(6) 2023.THIS MFR. REPORT ADDRESSES EVENT TWO (2) OF TWO (2). PER THE CUSTOMER, THE TUBE HOLDING THE REAGENT AND SAMPLE "SELF-EJECTED" FROM THE SUPPORT TRAY, WHICH CAUSED THE SAMPLE AND REAGENT OF THE CLEARVIEW PBP2A SA CULTURE COLONY TEST TO SPLASH ONTO THE COUNTERTOP AND ONTO THE INTACT SKIN OF THE LAB TECHNICIAN. THE TRAY WAS ON A FLAT STERILE SURFACE. THE CUSTOMER STATED AN ALLERGIC TEST WAS NOT INITIATED. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE EXPOSURE. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THEIR TREATMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17566033 ↗MalfunctionAug 17, 2023Leak/Splash; Improper or Incorrect Procedure or Method; Leak/Splash; Improper or Incorrect Procedure or Method
THE CUSTOMER REPORTED TWO (2) REAGENT AND SAMPLE EXPOSURE TO THE SKIN WITH THE CLEARVIEW PBP2A SA CULTURE COLONY TEST PERFORMED ON (B)(6) 2023.THIS MFR. REPORT ADDRESSES EVENT ONE (1) OF TWO (2). PER THE CUSTOMER, THE TUBE HOLDING THE REAGENT AND SAMPLE "SELF-EJECTED" FROM THE SUPPORT TRAY, WHICH CAUSED THE SAMPLE AND REAGENT OF THE CLEARVIEW PBP2A SA CULTURE COLONY TEST TO SPLASH ONTO THE COUNTERTOP AND ONTO THE INTACT SKIN OF THE LAB TECHNICIAN. THE TRAY WAS ON A FLAT STERILE SURFACE. THE CUSTOMER STATED AN ALLERGIC TEST WAS NOT INITIATED. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE EXPOSURE. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THEIR TREATMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17565993 ↗
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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