MEDLINE MPH30025SARecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 30888277191888), received between Jul 25, 2018 and Sep 28, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (10 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026False Negative Result

  It was reported that "our results are not accurate using these tests" and "Just this week we had 2 patients that tested negative on the Medline item, while testing positive on the QuickVue tests."

  Patient problems: Bacterial Infection

  MAUDE report 50914694 ↗
• MalfunctionSep 21, 2026Unexpected Color

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50841275 ↗
• MalfunctionSep 21, 2026Missing Test Results

  It was reported that TWO OF THE 25 IN BOX WERE NOT DISPLAYING RESULTS FOR PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50838087 ↗
• MalfunctionSep 9, 2026False Negative Result; No Device Output

  Patient problems: Pharyngitis

  MAUDE report 50699195 ↗
• MalfunctionSep 9, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that ¿We are not able to read test results for STREP A TEST STRIPS¿ and ¿the strips are showing blank with no results.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50690734 ↗
• MalfunctionSep 7, 2026Unable to Obtain Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50652883 ↗
• MalfunctionSep 4, 2026False Negative Result

  It was reported that "All test except for two came back negative, these are defective".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50610758 ↗
• MalfunctionSep 2, 2026Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50564692 ↗
• MalfunctionSep 1, 2026False Negative Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50546681 ↗
• MalfunctionSep 1, 2026Unable to Obtain Readings

  It was reported that "Customer ordered 3 boxes and opened one to preform strep tests and they all came back with no reading."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50544223 ↗
• MalfunctionJun 10, 2026False Negative Result

  IT WAS REPORTED THAT THE DEVICE IS SHOWING FALSE NEGATIVES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25458422 ↗
• MalfunctionMay 6, 2026Incorrect, Inadequate or Imprecise Result or Readings

  PER REPORT, "CUSTOMER CALLED IN AND STATED SHE PUT 4 DROPS IN EACH. AFTER 5 MINS, THE NEG SHOWS CORRECTLY BUT POSITIVE DOES NOT SHOW CORRECTLY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25094892 ↗
• MalfunctionJul 25, 2018False Negative Result; False Negative Result

  THE ISSUE WAS INITIALLY REPORTED BY THE DISTRIBUTOR. ON (B)(6) 2018, THE PATIENT ARRIVED AT THE FACILITY WITH CONGESTION AND A SORE THROAT THAT HAD BEEN OCCURRING FOR THREE TO FOUR DAYS. THE PATIENT ALSO PRESENTED WITH A RED THROAT AND WHITE SPOTS ON THE TONSILS. THE PATIENT WAS TESTED WITH A MEDLINE STREP A TEST STRIP USING A DUAL SWAB TECHNIQUE AND A NEGATIVE STREP A RESULT WAS OBTAINED. THE CUSTOMER STATED A BACTISWAB WAS USED FOR THE TEST INSTEAD OF THE KITTED MEDLINE STREP A TEST STRIP SWAB. THE CUSTOMER STATED THE SWAB USED WAS STERILE BUT WAS UNABLE TO CONFIRM IF RAYON TRANSPORT SWABS CONTAINING MODIFIED STUART'S OR AMIES LIQUID MEDIUM WERE USED. A CONFIRMATORY CULTURE WAS ALSO PERFORMED USING A BACTISWAB AND LATER PRODUCED A POSITIVE STREP A RESULT (THE DATE OF THE STREP A CULTURE RESULT COULD NOT BE PROVIDED PER THE CUSTOMER). ON (B)(6) 2018, THE PATIENT WAS PRESCRIBED 500 MG OF PENICILLIN VK, 2X/DAY FOR 10 DAYS BASED OFF THE POSITIVE CULTURE REPORT. PER THE CUSTOMER, ALTHOUGH THE PATIENT WAS DELAYED IN RECEIVING TREATMENT DUE TO THE MEDLINE STREP A TEST STRIP RESULT, NO ADVERSE PATIENT OUTCOME OCCURRED. TROUBLESHOOTING WAS CONDUCTED WITH THE CUSTOMER. THE CUSTOMER WAS ADV

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7720705 ↗
• MalfunctionJul 25, 2018False Negative Result; False Negative Result

  THE ISSUE WAS INITIALLY REPORTED BY THE DISTRIBUTOR. ON (B)(6) 2018, THE PATIENT ARRIVED AT THE FACILITY WITH A SORE THROAT THAT HAD BEEN OCCURRING FOR THREE DAYS. THE PATIENT REPORTED EXPOSURE TO STREP AND PRESENTED WITH A RED THROAT AND TONSIL ENLARGEMENT. THE PATIENT WAS TESTED WITH A MEDLINE STREP A TEST STRIP USING A DUAL SWAB TECHNIQUE AND A NEGATIVE STREP A RESULT WAS OBTAINED. THE CUSTOMER STATED A BACTISWAB WAS USED FOR THE TEST INSTEAD OF THE KITTED MEDLINE STREP A TEST STRIP SWAB. THE CUSTOMER STATED THE SWAB USED WAS STERILE BUT WAS UNABLE TO CONFIRM IF RAYON TRANSPORT SWABS CONTAINING MODIFIED STUART'S OR AMIES LIQUID MEDIUM WERE USED. A CONFIRMATORY CULTURE WAS ALSO PERFORMED USING A BACTISWAB AND LATER PRODUCED A POSITIVE STREP A RESULT (THE DATE OF THE STREP A CULTURE RESULT COULD NOT BE PROVIDED PER THE CUSTOMER). ON (B)(6) 2018, THE PATIENT REPORTED "FEELING BETTER" PRIOR TO TREATMENT. THE PATIENT WAS PRESCRIBED 500 MG OF PENICILLIN VK, 2X/DAY FOR 10 DAYS BASED OFF THE POSITIVE CULTURE REPORT. PER THE CUSTOMER, ALTHOUGH THE PATIENT WAS DELAYED IN RECEIVING TREATMENT DUE TO THE MEDLINE STREP A TEST STRIP RESULT, NO ADVERSE PATIENT OUTCOME OCCURRED. TROUBLESHOOTING

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7720668 ↗
• MalfunctionJul 25, 2018False Negative Result; False Negative Result

  THE ISSUE WAS INITIALLY REPORTED BY THE DISTRIBUTOR. ON (B)(6) 2018, THE PATIENT ARRIVED AT THE FACILITY WITH A SORE THROAT, BODY ACHES, FEVER, AND COUGH THAT HAD BEEN OCCURRING FOR ONE WEEK. THE PATIENT ALSO HAD A RED THROAT AND LARGE LYMPH NODES. THE PATIENT WAS TESTED WITH A MEDLINE STREP A TEST STRIP USING A DUAL SWAB TECHNIQUE AND A NEGATIVE STREP A RESULT WAS OBTAINED. THE CUSTOMER STATED A BACTISWAB WAS USED FOR THE TEST INSTEAD OF THE KITTED MEDLINE STREP A TEST STRIP SWAB. THE CUSTOMER STATED THE SWAB USED WAS STERILE BUT WAS UNABLE TO CONFIRM IF RAYON TRANSPORT SWABS CONTAINING MODIFIED STUART'S OR AMIES LIQUID MEDIUM WERE USED. A CONFIRMATORY CULTURE WAS ALSO PERFORMED USING A BACTISWAB AND LATER PRODUCED A POSITIVE STREP A RESULT (THE DATE OF THE STREP A CULTURE RESULT COULD NOT BE PROVIDED PER THE CUSTOMER). ON (B)(6) 2018, THE PATIENT REPORTED FEELING DIZZY. THE PATIENT WAS PRESCRIBED 500 MG OF PENICILLIN VK, 2X/DAY FOR 10 DAYS BASED OFF THE POSITIVE CULTURE REPORT. PER THE CUSTOMER, ALTHOUGH THE PATIENT WAS DELAYED IN RECEIVING TREATMENT DUE TO THE MEDLINE STREP A TEST STRIP RESULT, NO ADVERSE PATIENT OUTCOME OCCURRED. TROUBLESHOOTING WAS CONDUCTED WITH THE CUSTOMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7720619 ↗
• MalfunctionJul 25, 2018False Negative Result; False Negative Result

  THE ISSUE WAS INITIALLY REPORTED BY THE DISTRIBUTOR. ON (B)(6) 2018, THE PATIENT ARRIVED AT THE FACILITY WITH AN ITCHY, SORE THROAT AND A COUGH THAT HAD BEEN OCCURRING FOR TWO WEEKS. THE PATIENT ALSO HAD SWOLLEN LYMPH NODES AND RED ULCERS ON TONSILS. THE PATIENT WAS TESTED WITH A MEDLINE STREP A TEST STRIP USING A DUAL SWAB TECHNIQUE AND A NEGATIVE STREP A RESULT WAS OBTAINED. THE CUSTOMER STATED A BACTISWAB WAS USED FOR THE TEST INSTEAD OF THE KITTED MEDLINE STREP A TEST STRIP SWAB. THE CUSTOMER STATED THE SWAB USED WAS STERILE BUT WAS UNABLE TO CONFIRM IF RAYON TRANSPORT SWABS CONTAINING MODIFIED STUART'S OR AMIES LIQUID MEDIUM WERE USED. A CONFIRMATORY CULTURE WAS ALSO PERFORMED USING A BACTISWAB AND LATER PRODUCED A POSITIVE STREP A RESULT (THE DATE OF THE STREP A CULTURE RESULT COULD NOT BE PROVIDED PER THE CUSTOMER). PER THE CUSTOMER, THE PATIENT ALSO TESTED POSITIVE FOR MONONUCLEOSIS (MONO). ON (B)(6) 2018, THE PATIENT STILL HAD A SORE THROAT AND FATIGUE. THE PATIENT WAS PRESCRIBED 500 MG OF PENICILLIN VK, 2X/DAY FOR 10 DAYS BASED OFF THE POSITIVE CULTURE REPORT. PER THE CUSTOMER, ALTHOUGH THE PATIENT WAS DELAYED IN RECEIVING TREATMENT DUE TO THE MEDLINE STREP A TEST STRIP R

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7720546 ↗
• MalfunctionJul 25, 2018False Negative Result; False Negative Result

  THE ISSUE WAS INITIALLY REPORTED BY THE DISTRIBUTOR. ON (B)(6) 2018, THE PATIENT ARRIVED AT THE FACILITY WITH A SORE THROAT AND NAUSEA THAT HAD BEEN OCCURRING FOR FOUR DAYS. THE PATIENT WAS TESTED WITH A MEDLINE STREP A TEST STRIP USING A DUAL SWAB TECHNIQUE AND A NEGATIVE STREP A RESULT WAS OBTAINED. THE CUSTOMER STATED A BACTISWAB WAS USED FOR THE TEST INSTEAD OF THE KITTED MEDLINE STREP A TEST STRIP SWAB. THE CUSTOMER STATED THE SWAB USED WAS STERILE BUT WAS UNABLE TO CONFIRM IF RAYON TRANSPORT SWABS CONTAINING MODIFIED STUART'S OR AMIES LIQUID MEDIUM WERE USED. A CONFIRMATORY CULTURE WAS ALSO PERFORMED USING A BACTISWAB AND LATER PRODUCED A POSITIVE STREP A RESULT (THE DATE OF THE STREP A CULTURE RESULT COULD NOT BE PROVIDED PER THE CUSTOMER). ON (B)(6) 2018, THE PATIENT STILL HAD A SORE THROAT, FEVER, AND LARGE CERVICAL LYMPH NODES. THE PATIENT WAS PRESCRIBED 500 MG OF PENICILLIN VK, 2X/DAY FOR 10 DAYS BASED OFF THE POSITIVE CULTURE REPORT. PER THE CUSTOMER, ALTHOUGH THE PATIENT WAS DELAYED IN RECEIVING TREATMENT DUE TO THE MEDLINE STREP A TEST STRIP RESULT, NO ADVERSE PATIENT OUTCOME OCCURRED. TROUBLESHOOTING WAS CONDUCTED WITH THE CUSTOMER. THE CUSTOMER WAS ADVISED TO USE VA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7720461 ↗