AlereTM 92210Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10815845020130), received between Nov 2, 2017 and Jul 28, 2023 — classified as 2 injuries, 21 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (15 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

1. Aug 20, 2026Open, Classified

   hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.

   Z-3271-2026 · Root cause: Device Design · FDA record ↗

2. 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-1606-2022 · Root cause: Environmental control · FDA record ↗

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2023False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WHEN TESTING A PATIENT URINE SAMPLE WITH THE ALERE HCG CASSETTE (20 MIU/ML). THE PATIENT WAS BEING SCREENED FOR PREGNANCY PRIOR TO A HYSTERECTOMY. ANOTHER URINE SAMPLE WAS TESTED USING A MEDLINE HCG RAPID TEST, WITH A POSITIVE RESULT. A SERUM SAMPLE WAS THEN COLLECTED AND TESTED USING THE ATELLICA IM ANALYZER, WITH A POSITIVE RESULT. THE CUSTOMER STATED THAT THERE WAS NO IMPACT TO THE CUSTOMER FROM THE REPORTED FALSE NEGATIVE RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17420133 ↗
• MalfunctionMar 26, 2020False Negative Result; False Negative Result

  UNSPECIFIED DATE: PATIENT PRESENTED TO FACILITY AFTER OBTAINING A POSITIVE RESULT ON A HOME PREGNANCY TEST (BRAND/SPECIFICITY UNSPECIFIED). URINE SPECIMEN TESTED ON THE ALERE HCG CASSETTE AND A NEGATIVE RESULT WAS OBTAINED. A CONFIRMATORY BLOOD HCG WAS PERFORMED AND THE RESULT WAS POSITIVE AT >100 (UNITS NOT ABLE TO BE CONFIRMED). NO ADVERSE PATIENT OUTCOMES REPORTED. ALTHOUGH FURTHER INFORMATION WAS REQUESTED, NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9886803 ↗
• MalfunctionNov 22, 2019False Positive Result; False Positive Result

  (B)(6) 2019: A (B)(6) FEMALE PATIENT VISITED CLINIC FOR AN HCG TEST. PATIENT URINE WAS COLLECTED AT UNKNOWN TIME AND WAS TESTED USING THE ALERE HCG CASSETTE AT UNKNOWN TIME. A POSITIVE RESULT WAS OBTAINED ON THE ALERE HCG CASSETTE AT THE 3 MINUTE READ TIME. PATIENT SAMPLE WAS DRAWN SAME DAY AT AN UNKNOWN TIME AND WAS SENT FOR CONFIRMATORY TESTING ON THE DXI BECKMAN 800. THE QUANTITATIVE HCG PROVIDED A RESULT OF <1 MLU/ML ALTHOUGH FURTHER INFORMATION WAS REQUESTED, NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER. TROUBLESHOOTING OCCURRED WITH A DISCUSSION ABOUT POSSIBLE CAUSES FOR UNEXPECTED RESULTS FOCUSING ON PROPER SAMPLING TECHNIQUE, STORAGE CONDITIONS AND PATIENT SPECIFIC FACTORS PER THE PACKAGE INSERT (PI)-NO DEVIATIONS NOTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9365619 ↗
• MalfunctionOct 1, 2019False Positive Result; False Positive Result

  IT WAS REPORTED THAT A (B)(6) OLD PATIENT VISITED THE CLINIC AND AN HCG CASSETTE TEST WAS ADMINISTERED WITH A URINE SAMPLE. A FAINT POSITIVE RESULT OCCURRED. RETEST WAS ADMINISTERED TWO TIMES WITH A NEGATIVE RESULT. CONFIRMATORY TESTING WILL NOT BE CONDUCTED. THE PATIENT WAS NOT PROVIDED/WITHHELD TREATMENT NOR WERE THERE CHANGES IN MEDICATION DUE TO THE HCG RESULTS. NO ADVERSE PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9143348 ↗
• MalfunctionOct 1, 2019False Positive Result; False Positive Result

  IT WAS REPORTED THAT A (B)(6) OLD PATIENT VISITED THE CLINIC AND AN HCG CASSETTE TEST WAS ADMINISTERED. A FAINT POSITIVE RESULT OCCURRED. RETEST WAS ADMINISTERED 2 TIMES WITH A NEGATIVE RESULT. CONFIRMATORY TESTING WILL NOT BE CONDUCTED. THE PATIENT WAS NOT PROVIDED OR WITHHELD TREATMENT NOR WERE THERE CHANGES IN MEDICATION DUE TO THE HCG RESULTS TO THE CUSTOMER'S KNOWLEDGE. NO ADVERSE PATIENT OUTCOME. TROUBLESHOOTING OCCURRED WITH A DISCUSSION ABOUT THE FALSE POSITIVE EVENT AND POSSIBLE CAUSES SUCH AS TECHNIQUE, STORAGE, HANDLING, AND SPECIMEN FACTORS PER PACKAGE INSERT (PI)- NO DEVIATIONS NOTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9143344 ↗
• MalfunctionSep 27, 2019False Positive Result; False Positive Result

  (B)(6) 2018: EMPLOYEE URINE SPECIMEN WAS TESTED ON THE ALERE HCG CASSETTE AND A POSITIVE RESULT WAS OBTAINED. CONFIRMATORY TESTING WAS NOT PERFORMED. NO FURTHER INFORMATION PROVIDED. TROUBLESHOOTING OCCURRED WITH A DISCUSSION ABOUT POSSIBLE CAUSES FOR UNEXPECTED RESULTS FOCUSING ON PROPER SAMPLING TECHNIQUE, STORAGE CONDITIONS AND PATIENT SPECIFIC FACTORS PER THE PACKAGE INSERT (PI)-NO DEVIATIONS NOTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9127151 ↗
• MalfunctionSep 27, 2019False Positive Result; False Positive Result

  (B)(6) 2018: EMPLOYEE URINE SPECIMEN WAS TESTED ON THE ALERE HCG CASSETTE AND A POSITIVE RESULT WAS OBTAINED. CONFIRMATORY TESTING WAS NOT PERFORMED. NO FURTHER INFORMATION PROVIDED. TROUBLESHOOTING OCCURRED WITH A DISCUSSION ABOUT POSSIBLE CAUSES FOR UNEXPECTED RESULTS FOCUSING ON PROPER SAMPLING TECHNIQUE, STORAGE CONDITIONS AND PATIENT SPECIFIC FACTORS PER THE PACKAGE INSERT (PI)-NO DEVIATIONS NOTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9127144 ↗
• MalfunctionSep 27, 2019False Positive Result; False Positive Result

  (B)(6) 2018: PATIENT PRESENTED TO THE FACILITY FOR AN UNSPECIFIED REASON. PATIENT URINE SPECIMEN WAS TESTED ON THE ALERE HCG CASSETTE AND A POSITIVE RESULT WAS OBTAINED. CONFIRMATORY SERUM QUANT WAS PERFORMED AND THE RESULT WAS NEGATIVE (EXACT VALUE NOT PROVIDED). NO FURTHER INFORMATION PROVIDED. TROUBLESHOOTING OCCURRED WITH A DISCUSSION ABOUT POSSIBLE CAUSES FOR UNEXPECTED RESULTS FOCUSING ON PROPER SAMPLING TECHNIQUE, STORAGE CONDITIONS AND PATIENT SPECIFIC FACTORS PER THE PACKAGE INSERT (PI)-NO DEVIATIONS NOTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9127143 ↗
• MalfunctionSep 26, 2019False Positive Result; False Positive Result

  IT WAS REPORTED THAT FALSE POSITIVE OCCURRED WHEN USING THE HCG CASSETTE, SERUM HCG QUANT WAS NEGATIVE FOR PREGNANCY. ADDITIONAL TESTING OF THE URINE SAMPLE MAY HAVE INDICATED AN INTERFERENCE. CUSTOMER UNABLE TO PROVIDE FURTHER INFORMATION. ALTHOUGH REQUESTED, NO FURTHER INFORMATION HAS BEEN RECEIVED.

  Patient problems: No Information

  MAUDE report 9121646 ↗
• MalfunctionSep 25, 2019False Positive Result; False Positive Result

  ON (B)(6) 2017 A PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH POSSIBLY ABDOMINAL PAIN. (REPORTER WAS UNCERTAIN) AT 6PM A RAPID HGC WAS ORDERED WHICH DISPLAYED A POSITIVE RESULT. THE PATIENT HAD A HISTORY OF TUBAL LIGATION, EMPHATIC SHE WAS NOT PREGNANT. A SERUM QUANTITATIVE HCG TEST WAS ORDERED AND RETURNED AS WITH A NEGATIVE RESULT. NO TREATMENT OR MEDICATION WAS DELAYED AS A RESULT OF THE RAPID TEST. LMP WAS NOT AVAILABLE. ON (B)(6) 2019, THE REPORTER KNEW OF THE EVENT, THE PATIENT SAMPLE WAS DISCARDED THE DAY BEFORE BUT RETRIEVED, RETESTED WITH A NEGATIVE RESULT. BECAUSE THE CUSTOMER COULD NOT CONFIRM IF THE COLLECTION CUP OBTAINED ON (B)(6) 2017 WAS THAT OF THE SAME PATIENT TESTED ON (B)(6) 2017, THE CUSTOMER WAS NOT CONCERNED WITH THE POSSIBLE CONFLICTING RESULTS, BUT WAS CONCERNED WITH THE FP RESULT BETWEEN THE RAPID AND THE SERUM QUANT.

  Patient problems: No Information

  MAUDE report 9114382 ↗
• MalfunctionAug 21, 2019False Negative Result; False Negative Result

  IT WAS REPORTED THAT A PATIENT WHO HAD 4 POSITIVE AT HOME PREGNANCY TEST RESULTS WAS TESTED AT THE CLINIC ON THE HCG CASSETTE WITH A NEGATIVE RESULT. THE PATIENT WAS SET TO START MELATONIN BUT IT WAS WITHHELD DUE TO THE RESULT ON THE HCG CASSETTE SHE RETURNED HOME, ADMINISTERED ANOTHER AT HOME PREGNANCY TEST WHICH WAS POSITIVE AGAIN. THE PATIENT THEN RETURNED TO THE CLINIC, HAD A FALSE NEGATIVE RESULT AGAIN WITH A CONFIRMATORY LAB SERUM QUANT OF 125 MIU/ML. TROUBLESHOOTING OCCURRED WITH A DISCUSSION ABOUT THE FALSE NEGATIVE EVENT AND POSSIBLE CAUSES SUCH AS TECHNIQUE, STORAGE, HANDLING, AND SPECIMEN FACTORS PER PACKAGE INSERT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8919079 ↗
• MalfunctionMay 2, 2018False Negative Result; False Negative Result

  THE PATIENT'S LAST MENSTRUAL PERIOD WAS (B)(6) "2018." THE PATIENT WAS REPORTED AS HAVING AN IRREGULAR MENSTRUAL PERIOD. ON (B)(6) 2018, THE PATIENT TESTED USING FOUR HOME PREGNANCY TESTS AND RECEIVED A POSITIVE RESULT EACH TIME. ONE HOME PREGNANCY TEST WAS TESTED IN THE MORNING AND THREE HOME PREGNANCY TESTS WERE TESTED IN THE EVENING. ON (B)(6) 2018, THE PATIENT PRESENTED AT THE FACILITY TO CONFIRM THE PREGNANCY BECAUSE THE PATIENT WAS SCHEDULED FOR A SURGERY. THE PATIENT REQUESTED A BLOOD TEST BUT THE CUSTOMER OPTED TO USE AN ALERE HCG CASSETTE. A NON-FIRST MORNING URINE SAMPLE WAS COLLECTED AND PRODUCED A NEGATIVE HCG RESULT AT THE 3 MINUTE READ TIME AND A POSITIVE HCG RESULT 5 TO 10 MINUTES LATER (REFER TO MDR 2027969-2018-00046). THE CUSTOMER THEN RETESTED USING A TEST FROM A SECOND LOT OF ALERE HCG CASSETTES WITH A NEGATIVE HCG RESULT AT THE 3 MINUTE READ TIME. APPROXIMATELY 5 TO 10 MINUTES LATER, THE CUSTOMER OBSERVED A "CLEAR POSITIVE" HCG RESULT ON THE ALERE HCG CASSETTE. A BLOOD SAMPLE WAS SUBSEQUENTLY DRAWN AND PRODUCED A QUANTITATIVE HCG RESULT OF 26 MIU/ML. THE SURGERY WAS NOT PERFORMED BASED ON THE LABORATORY RESULT. FORTY MINUTES AFTER LEAVING THE FACILITY, THE PATI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7482140 ↗
• MalfunctionMar 28, 2018False Negative Result; False Negative Result

  THE PATIENT'S LAST MENSTRUAL PERIOD WAS (B)(6) 2018. THE PATIENT PREVIOUSLY RECEIVED THREE POSITIVE RESULTS USING FIRST RESPONSE BRAND HOME PREGNANCY TESTS. ON (B)(6) 2018, THE PATIENT WAS TESTED AT THE FACILITY TO CONFIRM THE RESULTS OF THE HOME PREGNANCY TESTS AND PRESENTED WITH SYMPTOMS OF NAUSEA. A URINE SAMPLE WAS COLLECTED AND PRODUCED A NEGATIVE RESULT AT THE 3 MINUTE READ TIME USING AN ALERE HCG CASSETTE. HOWEVER, THE CUSTOMER OBSERVED A POSITIVE RESULT ON THE ALERE HCG CASSETTE AFTER 45 MINUTES. THE PATIENT WAS INSTRUCTED TO FOLLOW UP WITH HER PHYSICIAN OR RETURN FOR A RETEST. THE CUSTOMER STATED A FIRST-MORNING SAMPLE IS TYPICALLY NOT USED. TROUBLESHOOTING WAS CONDUCTED WITH THE CUSTOMER. THE CUSTOMER WAS ADVISED THAT VERY DILUTED URINE SPECIMENS (AS INDICATED BY LOW SPECIFIC GRAVITY) MAY NOT CONTAIN REPRESENTATIVE LEVELS OF HCG. ADDITIONALLY, FALSE NEGATIVE RESULTS MAY OCCUR WHEN THE LEVELS OF HCG ARE BELOW THE SENSITIVITY LEVEL OF THE TEST. WHEN PREGNANCY IS SUSPECTED, A FIRST MORNING URINE SPECIMEN SHOULD BE COLLECTED 48 HOURS LATER AND TESTED. THIS TEST PROVIDES A PRESUMPTIVE DIAGNOSIS FOR PREGNANCY. A CONFIRMED PREGNANCY DIAGNOSIS SHOULD ONLY BE MADE BY A PHYSICIAN A

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7379567 ↗
• InjuryMar 28, 2018False Negative Result; False Negative Result

  THE PATIENT PREVIOUSLY RECEIVED A POSITIVE RESULT USING A HOME PREGNANCY TEST. ON (B)(6) 2018, THE PATIENT WAS TESTED AT THE FACILITY TO CONFIRM THE RESULT OF THE HOME PREGNANCY TEST. A URINE SAMPLE WAS COLLECTED AND PRODUCED A NEGATIVE RESULT USING AN ALERE HCG CASSETTE. THE PATIENT WAS INSTRUCTED TO FOLLOW UP WITH HER PHYSICIAN OR RETURN FOR A RETEST. ON (B)(6) 2018, THE PATIENT ARRIVED AT THE EMERGENCY ROOM PRESENTING WITH BLEEDING AND PAIN. AN ULTRASOUND WAS CONDUCTED AND CONFIRMED THE PREGNANCY. THE PATIENT WAS DETERMINED TO BE FIVE WEEKS PREGNANT. THE PATIENT WAS LATER DISCHARGED FROM THE EMERGENCY ROOM WITHOUT FURTHER BLEEDING OR PAIN. THE CUSTOMER STATED A FIRST-MORNING SAMPLE IS TYPICALLY NOT USED. TROUBLESHOOTING WAS CONDUCTED WITH THE CUSTOMER. THE CUSTOMER WAS ADVISED THAT VERY DILUTED URINE SPECIMENS (AS INDICATED BY LOW SPECIFIC GRAVITY) MAY NOT CONTAIN REPRESENTATIVE LEVELS OF HCG. ADDITIONALLY, FALSE NEGATIVE RESULTS MAY OCCUR WHEN THE LEVELS OF HCG ARE BELOW THE SENSITIVITY LEVEL OF THE TEST. WHEN PREGNANCY IS SUSPECTED, A FIRST MORNING URINE SPECIMEN SHOULD BE COLLECTED 48 HOURS LATER AND TESTED. THIS TEST PROVIDES A PRESUMPTIVE DIAGNOSIS FOR PREGNANCY. A CONFIRME

  Patient problems: Menstrual Irregularities

  MAUDE report 7378741 ↗
• MalfunctionMar 28, 2018False Negative Result; False Negative Result

  THE PATIENT'S LAST MENSTRUAL PERIOD WAS (B)(6) 2018. THE PATIENT PREVIOUSLY RECEIVED A POSITIVE RESULT USING A HOME PREGNANCY TEST. ON (B)(6) 2018, THE PATIENT WAS TESTED AT THE FACILITY TO CONFIRM THE RESULT OF THE HOME PREGNANCY TEST AND PRESENTED WITH SYMPTOMS OF NAUSEA. A URINE SAMPLE WAS COLLECTED AND PRODUCED A NEGATIVE RESULT USING AN ALERE HCG CASSETTE. THE PATIENT REPORTED THAT LATER LABORATORY BLOOD WORK FROM (B)(6) CONFIRMED A PREGNANCY. THE CUSTOMER STATED A FIRST-MORNING SAMPLE IS TYPICALLY NOT USED. TROUBLESHOOTING WAS CONDUCTED WITH THE CUSTOMER. THE CUSTOMER WAS ADVISED THAT VERY DILUTED URINE SPECIMENS (AS INDICATED BY LOW SPECIFIC GRAVITY) MAY NOT CONTAIN REPRESENTATIVE LEVELS OF HCG. ADDITIONALLY, FALSE NEGATIVE RESULTS MAY OCCUR WHEN THE LEVELS OF HCG ARE BELOW THE SENSITIVITY LEVEL OF THE TEST. WHEN PREGNANCY IS SUSPECTED, A FIRST MORNING URINE SPECIMEN SHOULD BE COLLECTED 48 HOURS LATER AND TESTED. THIS TEST PROVIDES A PRESUMPTIVE DIAGNOSIS FOR PREGNANCY. A CONFIRMED PREGNANCY DIAGNOSIS SHOULD ONLY BE MADE BY A PHYSICIAN AFTER ALL CLINICAL AND LABORATORY FINDINGS HAVE BEEN EVALUATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7378658 ↗
• MalfunctionMar 28, 2018False Negative Result; False Negative Result

  THE PATIENT WAS TESTED AT THE FACILITY DUE TO SUSPECTED PREGNANCY. A URINE SAMPLE WAS COLLECTED AND PRODUCED A NEGATIVE RESULT USING AN ALERE HCG CASSETTE. THE PATIENT WAS INSTRUCTED TO FOLLOW UP WITH HER PHYSICIAN OR RETURN FOR A RETEST. ON A LATER DATE, THE PATIENT WENT TO THE EMERGENCY ROOM FOR AN UNKNOWN REASON. A PREGNANCY WAS CONFIRMED BY EITHER ULTRASOUND OR BLOOD WORK. THE CUSTOMER STATED A FIRST-MORNING SAMPLE IS TYPICALLY NOT USED. NO ADDITIONAL INFORMATION WAS PROVIDED. TROUBLESHOOTING WAS CONDUCTED WITH THE CUSTOMER. THE CUSTOMER WAS ADVISED THAT VERY DILUTED URINE SPECIMENS (AS INDICATED BY LOW SPECIFIC GRAVITY) MAY NOT CONTAIN REPRESENTATIVE LEVELS OF HCG. ADDITIONALLY, FALSE NEGATIVE RESULTS MAY OCCUR WHEN THE LEVELS OF HCG ARE BELOW THE SENSITIVITY LEVEL OF THE TEST. WHEN PREGNANCY IS SUSPECTED, A FIRST MORNING URINE SPECIMEN SHOULD BE COLLECTED 48 HOURS LATER AND TESTED. THIS TEST PROVIDES A PRESUMPTIVE DIAGNOSIS FOR PREGNANCY. A CONFIRMED PREGNANCY DIAGNOSIS SHOULD ONLY BE MADE BY A PHYSICIAN AFTER ALL CLINICAL AND LABORATORY FINDINGS HAVE BEEN EVALUATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7378558 ↗
• MalfunctionDec 12, 2017False Negative Result; False Negative Result

  ON (B)(6) 2017, THE PATIENT ARRIVED IN THE EMERGENCY DEPARTMENT AND A URINE SAMPLE WAS COLLECTED. THE ALERE HCG CASSETTE PRODUCED A NEGATIVE HCG RESULT. THE PATIENT INSISTED SHE WAS PREGNANT AND 10 MINUTES LATER A SECOND ALERE HCG CASSETTE PRODUCED A POSITIVE HCG RESULT. THE PATIENT WAS DETERMINED TO BE (B)(6) PREGNANT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7109647 ↗
• InjuryDec 7, 2017False Negative Result; False Negative Result

  ON (B)(6) 2017, THE PATIENT ARRIVED AT THE EMERGENCY DEPARTMENT (ED) AT 4:57 PM AND WAS ADMITTED FOR SEVERE RIGHT-SIDED ABDOMINAL PAIN. A URINE SAMPLE WAS COLLECTED AND AT 7:04 PM THE ALERE HCG CASSETTE PRODUCED A NEGATIVE HCG RESULT. A TRANSVAGINAL PELVIS ULTRASOUND WAS CONDUCTED AT 8:21 PM AND SHOWED A POSSIBLE CORPUS LUTEAL CYST IN THE RIGHT SIDE. THE ULTRASOUND ALSO SHOWED A POSSIBLE VERY EARLY INTRAUTERINE PREGNANCY. AS A NEGATIVE RESULT WAS RECEIVED USING THE ALERE HCG CASSETTE, AN ABDOMEN PELVIS WITH CONTRAST CT WAS CONDUCTED TO EVALUATE THE PATIENT FOR APPENDICITIS GIVEN CONTINUED PAIN. AT 9:01 PM, THE CT SCAN RESULT WAS UNREMARKABLE. AT 10:17 PM, AN HCG TEST USING THE SIEMENS CENTAUR CP WAS ORDERED ON A SAMPLE COLLECTED EARLIER. AT 11:05 PM, THE SIEMENS CENTAUR CP PRODUCED A POSITIVE HCG RESULT OF 1312 MIU/ML. THE CUSTOMER ALSO MENTIONED RECEIVING 4-5 FALSE NEGATIVE RESULTS ON MULTIPLE PATIENTS USING THE ALERE HCG CASSETTE BUT COULD NOT PROVIDE ANY ADDITIONAL INFORMATION.

  Patient problems: No Code Available

  MAUDE report 7097966 ↗
• MalfunctionNov 2, 2017False Negative Result; False Negative Result

  THE PATIENT'S LAST MENSTRUAL PERIOD WAS REPORTED TO BE (B)(6) 2017. THE PATIENT RECEIVED TWO POSITIVE HCG RESULTS ON HOME PREGNANCY TESTS ON (B)(6) 2017. ON (B)(6) 2017, THE PATIENT WENT TO FACILITY TO CONFIRM PREGNANCY. A NON-FIRST MORNING URINE SAMPLE WAS COLLECTED AND AN ALERE HCG CASSETTE FROM AN ALTERNATE LOT PRODUCED A NEGATIVE HCG RESULT AT THE READ TIME OF 3 MINUTES. HOWEVER, THE CUSTOMER REPORTED THAT A POSITIVE RESULT DEVELOPED AT 4 MINUTES (THIS INCIDENT IS REPORTED UNDER MDR 2027969-2017-00165). A SERUM SAMPLE WAS COLLECTED AND PRODUCED A POSITIVE HCG QUANTITATIVE RESULT OF 94 MIU/ML. THE PATIENT'S URINE SAMPLE WAS THEN SENT TO A SISTER FACILITY TO BE TESTED USING THE COMPLAINT LOT OF ALERE HCG CASSETTES. ON (B)(6) 2017, THE URINE SAMPLE PRODUCED A NEGATIVE HCG RESULT AT THE READ TIME OF 3 MINUTES USING THE COMPLAINT LOT OF ALERE HCG CASSETTES. HOWEVER, THE CUSTOMER REPORTED THAT A POSITIVE RESULT DEVELOPED AT 4 MINUTES. THE SAMPLE WAS ALSO TESTED WITH A SIEMENS CLINITEST HCG TEST AND PRODUCED A POSITIVE HCG RESULT. TROUBLESHOOTING WAS PROVIDED TO THE CUSTOMER. THE CUSTOMER WAS ADVISED SOME PATIENTS MAY TEST NEGATIVE EARLY IN THE PREGNANCY IF THE URINE HCG IS BELOW THE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6998328 ↗
• MalfunctionNov 2, 2017False Negative Result; False Negative Result

  THE PATIENT'S LAST MENSTRUAL PERIOD WAS REPORTED TO BE (B)(6) 2017. THE PATIENT RECEIVED TWO POSITIVE HCG RESULTS ON HOME PREGNANCY TESTS ON (B)(6) 2017. ON (B)(6) 2017, THE PATIENT WENT TO FACILITY TO CONFIRM PREGNANCY. A NON-FIRST MORNING URINE SAMPLE WAS COLLECTED AND AN ALERE HCG CASSETTE PRODUCED A NEGATIVE HCG RESULT AT THE READ TIME OF 3 MINUTES. HOWEVER, THE CUSTOMER REPORTED THAT A POSITIVE RESULT DEVELOPED AT 4 MINUTES. A SERUM SAMPLE WAS COLLECTED AND PRODUCED A POSITIVE HCG QUANTITATIVE RESULT OF 94 MIU/ML. THE PATIENT'S URINE SAMPLE WAS THEN SENT TO A SISTER FACILITY AND TESTED USING A DIFFERENT LOT OF ALERE HCG CASSETTES. THIS EVENT IS REPORTED UNDER MDR 2027969-2017-00164. ON (B)(6) 2017, THE URINE SAMPLE WAS ALSO TESTED WITH A SIEMENS CLINITEST HCG TEST AND PRODUCED A POSITIVE HCG RESULT. TROUBLESHOOTING WAS PROVIDED TO THE CUSTOMER. THE CUSTOMER WAS ADVISED SOME PATIENTS MAY TEST NEGATIVE EARLY IN THE PREGNANCY IF THE URINE HCG IS BELOW THE 20 MIU/ML CUT-OFF, OR VERY DILUTE URINE SPECIMENS MAY NOT CONTAIN REPRESENTATIVE LEVELS OF HCG. PER THE PACKAGE INSERT, IF PREGNANCY IS SUSPECTED, FIRST MORNING URINE SHOULD BE COLLECTED 48 HOURS LATER AND TESTED OR ALTERNATE CO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6998312 ↗
• MalfunctionNov 2, 2017False Negative Result; False Negative Result

  THE PATIENT'S LAST MENSTRUAL PERIOD WAS REPORTED AS (B)(6) 2017. ON (B)(6) 2017, THE PATIENT WENT TO FACILITY TO CONFIRM A THIRD PREGNANCY. THE PATIENT HAD RECEIVED POSITIVE HCG RESULTS USING HOME PREGNANCY TESTS PRIOR TO THE FACILITY VISIT. A NON-FIRST MORNING URINE SAMPLE WAS COLLECTED AND AN ALERE HCG CASSETTE FROM AN ALTERNATE LOT PRODUCED A NEGATIVE HCG RESULT AT THE READ TIME OF 3 MINUTES. HOWEVER, THE CUSTOMER REPORTED THAT A POSITIVE RESULT DEVELOPED SEVERAL MINUTES LATER (THIS INCIDENT WAS REPORTED UNDER MDR 2027969-2017-00162). A SERUM SAMPLE WAS COLLECTED AND PRODUCED A POSITIVE HCG QUANTITATIVE RESULT OF 56 MIU/ML. THE PATIENT'S URINE SAMPLE WAS THEN SENT TO A SISTER FACILITY. ON (B)(6) 2017, THE URINE SAMPLE WAS TESTED AT THE SISTER FACILITY USING THE COMPLAINT LOT OF ALERE HCG CASSETTES. THE ALERE HCG CASSETTE PRODUCED A NEGATIVE HCG RESULT AT THE READ TIME OF 3 MINUTES. HOWEVER, THE CUSTOMER REPORTED THAT A FAINT POSITIVE RESULT DEVELOPED AT 5 MINUTES AND WAS CLEARLY EVIDENT BY 20 MINUTES. TROUBLESHOOTING WAS PROVIDED TO THE CUSTOMER. THE CUSTOMER WAS ADVISED SOME PATIENTS MAY TEST NEGATIVE EARLY IN THE PREGNANCY IF THE URINE HCG IS BELOW THE 20 MIU/ML CUT-OFF, OR VE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6998211 ↗
• MalfunctionNov 2, 2017False Negative Result; False Negative Result

  THE PATIENT'S LAST MENSTRUAL PERIOD WAS REPORTED AS (B)(6) 2017. ON (B)(6) 2017, THE PATIENT WENT TO FACILITY TO CONFIRM A THIRD PREGNANCY. THE PATIENT HAD RECEIVED POSITIVE HCG RESULTS USING HOME PREGNANCY TESTS PRIOR TO THE FACILITY VISIT. A NON-FIRST MORNING URINE SAMPLE WAS COLLECTED AND THE ALERE HCG CASSETTE PRODUCED A NEGATIVE HCG RESULT AT THE READ TIME OF 3 MINUTES. HOWEVER, THE CUSTOMER REPORTED THAT A POSITIVE RESULT DEVELOPED SEVERAL MINUTES LATER. A SERUM SAMPLE WAS COLLECTED AND PRODUCED A POSITIVE HCG QUANTITATIVE RESULT OF 56 MIU/ML. TROUBLESHOOTING WAS PROVIDED TO THE CUSTOMER. THE CUSTOMER WAS ADVISED SOME PATIENTS MAY TEST NEGATIVE EARLY IN THE PREGNANCY IF THE URINE HCG IS BELOW THE 20 MIU/ML CUT-OFF, OR VERY DILUTE URINE SPECIMENS MAY NOT CONTAIN REPRESENTATIVE LEVELS OF HCG. THE PATIENT'S URINE SAMPLE WAS SENT TO A SISTER FACILITY AND TESTED USING A DIFFERENT LOT OF ALERE HCG CASSETTES. THIS EVENT IS REPORTED UNDER MDR 2027969-2017-00163.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6998080 ↗
• MalfunctionNov 2, 2017False Negative Result; False Negative Result

  ON (B)(6) 2017, THE PATIENT WENT TO FACILITY OF AN IUD PLACEMENT. THE PATIENT REPORTED HAVING HAD SEXUAL CONTACT WITHIN THE LAST TWO WEEKS. A NON-FIRST MORNING URINE SAMPLE WAS COLLECTED AND THE ALERE HCG CASSETTE PRODUCED A NEGATIVE HCG RESULT AT THE READ TIME OF 3 MINUTES. HOWEVER, THE CUSTOMER REPORTED THAT A POSITIVE RESULT DEVELOPED SEVERAL MINUTES LATER. A SERUM SAMPLE WAS COLLECTED AND PRODUCED A POSITIVE HCG QUANTITATIVE RESULT OF 87 MIU/ML. BASED ON THE POSITIVE HCG SERUM QUANTITATIVE RESULT, THE IUD WAS NOT PLACED. TROUBLESHOOTING WAS PROVIDED TO THE CUSTOMER. THE CUSTOMER WAS ADVISED SOME PATIENTS MAY TEST NEGATIVE EARLY IN THE PREGNANCY IF THE URINE HCG IS BELOW THE 20 MIU/ML CUT-OFF, OR VERY DILUTE URINE SPECIMENS MAY NOT CONTAIN REPRESENTATIVE LEVELS OF HCG.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6997667 ↗