AlereTMRecalls & reported problems across all models

We found 5 models of AlereTM by Alere San Diego, Inc. in the FDA's device registry (GUDID). Together they are named in 43 adverse event reports in the FDA's MAUDE database, received between Nov 2, 2017 and Mar 5, 2026 — classified as 3 injuries, 40 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (21 reports).

5 FDA recall records name at least one of these models by its device identifier, 5 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

AlereTM recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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-3274-2026 · Root cause: Device Design · Recall details · FDA record ↗

2. 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-3273-2026 · Root cause: Device Design · Recall details · FDA record ↗

3. 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-3272-2026 · Root cause: Device Design · Recall details · FDA record ↗

4. 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 · names 2 of these models · Recall details · FDA record ↗

5. 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 · names 2 of these models · Recall details · FDA record ↗

Most reported AlereTM problems

AlereTM models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• AlereTM 92210

  Visual, Pregnancy Hcg, Prescription Use
  2 recalls23 reports
• AlereTM 92211

  Visual, Pregnancy Hcg, Prescription Use
  2 recalls2 reports
• AlereTM 92217

  Visual, Pregnancy Hcg, Prescription Use
  1 recall8 reports
• AlereTM 92215

  Visual, Pregnancy Hcg, Prescription Use
  1 recall6 reports
• AlereTM 92225

  Visual, Pregnancy Hcg, Prescription Use
  1 recall4 reports

Recent AlereTM adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2026False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WHEN TESTING A PATIENT WITH THE ALERE HCG DIPSTICK. THE PATIENT DENIED BEING SEXUALLY ACTIVE. THE TEST WAS REPEATED, HOWEVER THE RESULT WAS NOT PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24520766 ↗
• MalfunctionMar 5, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED "INDETERMINATE" RESULT WHEN TESTING A PATIENT WITH THE ALERE HCG DIPSTICK. THE PATIENT WAS TESTED, THEN PROVIDED A SECOND URINE SAMPLE, WHICH WAS ALSO TESTED. THE SPECIFIC RESULTS OBTAINED WERE NOT PROVIDED. IT IS CONSERVATIVELY ASSUMED THAT AT LEAST ONE RESULT WAS BELIEVED TO BE FALSE. NO ADDITIONAL INFORMATION WAS PROVIDED. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24520708 ↗
• MalfunctionDec 17, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING A TOTAL OF 2 FALSE POSITIVE HCG RESULTS WHILE TESTING ALERE HCG (SERUM/URINE) DEVICES ON TWO DIFFERENT PATIENTS. THE SECOND PATIENT PRESENTED ON (B)(6) 2024 PRIOR TO UNDERGOING AN UNSPECIFIED SURGICAL PROCEDURE. THE PATIENT PROVIDED A FRESH URINE SAMPLE WAS PROVIDED, WHICH WAS TESTED, AND THE RESULTS WERE READ AT 3 MINUTES. A FAINT POSITIVE RESULT WAS REPORTED. AS A RESULT OF THE POSITIVE RESULT, RETESTING WAS PERFORMED USING A DIFFERENT DEVICE FROM THE SAME KIT AND A NEGATIVE HCG RESULT WAS OBTAINED. THE CUSTOMER REPORTED NO ADVERSE EVENTS OCCURRED AS A RESULT OF THE FALSE POSITIVE RESULT. NO FURTHER INFORMATION WAS PROVIDED. SEE MDR 2027969-2024-00217 FOR THE MDR FOR THE FIRST PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20958916 ↗
• MalfunctionDec 17, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING A TOTAL OF 2 FALSE POSITIVE HCG RESULTS WHILE TESTING ALERE HCG (SERUM/URINE) DEVICES ON TWO DIFFERENT PATIENTS. THE FIRST PATIENT PRESENTED ON (B)(6) 2024 PRIOR TO UNDERGOING AN UNSPECIFIED SURGICAL PROCEDURE. THE PATIENT PROVIDED A FRESH URINE SAMPLE WAS PROVIDED, WHICH WAS TESTED, AND THE RESULTS WERE READ AT 3 MINUTES. A FAINT POSITIVE RESULT WAS REPORTED. AS A RESULT OF THE POSITIVE RESULT, RETESTING WAS PERFORMED USING A DIFFERENT DEVICE FROM THE SAME KIT AND A NEGATIVE HCG RESULT WAS OBTAINED. THE CUSTOMER REPORTED NO ADVERSE EVENTS OCCURRED AS A RESULT OF THE FALSE POSITIVE RESULT. NO FURTHER INFORMATION WAS PROVIDED. SEE MDR 2027969-2024-00218 FOR THE MDR FOR THE SECOND PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20958595 ↗
• MalfunctionJun 21, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING FALSE POSITIVE HCG RESULTS WHILE USING ALERE HCG STRIP URINE TESTS FOR TWO PATIENTS. THE SECOND PATIENT PRESENTED ON (B)(6) 2024 FOR HCG TESTING PRIOR TO AN IUD PLACEMENT FOR CONTRACEPTION. THE PATIENT PROVIDED A FRESH URINE SAMPLE. THREE DROPS OF URINE WERE APPLIED TO THE DEVICE AND THE RESULTS WERE READ AT 3 MINUTES 30 SECONDS YIELDING A POSITIVE HCG RESULT. THE CUSTOMER REPORTED AN ADDITIONAL TEST WAS PERFORMED WHICH ALSO YIELDED A POSITIVE HCG RESULT, HOWEVER IT IS UNCLEAR WHICH DEVICE YIELDED THIS ADDITIONAL FALSE HCG RESULT. CONFIRMATORY BLOOD HCG TESTING WAS PERFORMED WHICH YIELDED A NEGATIVE RESULT. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19589564 ↗
• MalfunctionJun 21, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING FALSE POSITIVE HCG RESULTS WHILE USING ALERE HCG STRIP URINE TESTS FOR TWO PATIENTS. THE FIRST PATIENT PRESENTED ON (B)(6) 2024 FOR HCG TESTING, PRIOR TO NEXPLANON PLACEMENT FOR CONTRACEPTION. THE PATIENT PROVIDED A FRESH URINE SAMPLE. THREE DROPS OF URINE WERE APPLIED TO THE DEVICE AND THE RESULTS WERE READ AT 4 MINUTES YIELDING A POSITIVE HCG RESULT. CONFIRMATORY BLOOD HCG TESTING WAS PERFORMED WHICH YIELDED A NEGATIVE RESULT. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19585753 ↗
• 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 ↗
• MalfunctionSep 13, 2022False Positive Result; False Positive Result

  UNSPECIFIED DATE: CUSTOMER REPORTED SEVERAL FALSE POSITIVE RESULTS WHEN TESTING WITH THE ALERE HCG COMBO CASSETTE. NO ADVERSE OUTCOMES REPORTED. THE EXACT FREQUENCY OR NUMBER OF PATIENTS INVOLVED WAS NOT PROVIDED. ALTHOUGH REQUESTED, FURTHER INFORMATION WAS NOT PROVIDED AT INTAKE.

  Patient problems: Insufficient Information

  MAUDE report 15414645 ↗
• MalfunctionMay 17, 2022False Positive Result; False Positive Result

  THE CUSTOMER REPORTED THAT 2 FALSE POSITIVE RESULTS OCCURRED WHEN USING A URINE SAMPLE ON THE ALERE HCG COMBO TEST DEVICE (SERUM/URINE) PRIOR TO AN ELECTIVE COLONOSCOPY PROCEDURE. CONFIRMATORY TESTS WITH A BLOOD SAMPLE WERE PERFORMED WITH AN UNKNOWN METHOD, BHCG QUANT ON (B)(6) 2022 WAS A NEGATIVE RESULT, 0.2MIU/ML. THE PROCEDURE WAS TO BE RESCHEDULED. NO ADVERSE EVENS OCCURRED DUE TO THE DELAY IN THE COLONOSCOPY PROCEDURE. MEDICATIONS: ADDERALL XR 15 MG EXTENDED RELEASE CAPSULE TAKE 15 MG BY MOUTH EVERY MORNING. DULCOLAX 5 MG ENTERIC COATED TABLET PLEASE TAKE AS DIRECTED AT BEDTIME 2 DAYS PRIOR TO GI PROCEDURE. CATAPRES 0.1 MG TABLET TAKE 1/2 TO 1 TABLET BY MOUTH AT BEDTIME AS NEEDED FOR SLEEP. FLEXERIL 10 MG TABLET TAKE 1 TABLET BY MOUTH 2 TIMES A DAY AS NEEDED FOR MUSCLE SPASMS FOR UP TO 7 DAYS. PRISTIQ 100 MG EXTENDED RELEASE TABLET TAKE BY MOUTH DAILY. AVAPRO 300 MG TABLET. LISINOPRIL 5 MG TABLET TAKE 5 MG BY MOUTH DAILY WITH FOOD. MULTIVITAMIN TABLET TAKE 1 TABLET BY MOUTH DAILY. PRILOSEC 40 MG DELAYED RELEASE CAPSULE TAKE 40 MG BY MOUTH DAILY WITH FOOD. GOLYTELY SOLUTION PLEASE TAKE HALF OF PREP SOLUTION AT 9 PM NIGHT BEFORE GI PROCEDURE, AND SECOND HALF OF PREP 6 HOURS PRIO

  Patient problems: Insufficient Information

  MAUDE report 14419587 ↗
• MalfunctionMay 17, 2022False Positive Result; False Positive Result

  THE CUSTOMER REPORTED 4 FALSE POSITIVE RESULTS WHEN USING A URINE SAMPLE ON THE ALERE HCG TEST DEVICE (SERUM/URINE) PRIOR TO AN ELECTIVE COLONOSCOPY PROCEDURE. CONFIRMATORY BLOOD TESTS WERE PERFORMED WITH AN UNKNOWN METHOD WITH NEGATIVE RESULTS, BHCG QUANT ON (B)(6) 2022 WAS <0.2. THE PROCEDURE WAS PERFORMED THE FOLLOWING DAY. NO ADVERSE EVENTS OCCURRED DUE THE DELAY IN THE COLONOSCOPY PROCEDURE. MEDICATIONS: DULCOLAX 5 MG EC 2 DAYS BEFORE PROCEDURE. BLISOVI 24 FE 1-20 MG-MCG PO QD. GOLYTELY 1/2 SOL. 9PM NIGHT BEFORE PROCEDURE. GOLYTELY 1/2 SOL. 6 HOURS BEFORE PROCEDURE. ZOLOFT 50 MG TAB 100 MG PO QD. ZOLOFT 100 MG TAB 100 MG PO QD. MULTIVITAMIN 1 TAB PO QD WITH FOOD. MULTIPLE VITAMINS/WOMENS PO 1 QD.

  Patient problems: Insufficient Information

  MAUDE report 14419320 ↗
• MalfunctionJul 20, 2021False Positive Result; False Positive Result

  (B)(6) 2021: PATIENT PRESENTED TO THE FACILITY COMPLAINING OF NAUSEA AND VOMITING. PER CLINIC WORKFLOW, MA WILL COLLECT URINE FOR URINE DIPSTICK AND URINE HCG ON FEMALES THAT ARE OF CHILD BEARING AGE. A PATIENT URINE SPECIMEN WAS TESTED ON THE HCG ONE STEP PREGNANCY TEST DEVICE KIT AND A FALSE POSITIVE RESULT WAS OBTAINED. TWO OTHER TESTS FROM THE SAME BOX HAD PROVIDED A NEGATIVE RESULT FOR THE PATIENT AND A THIRD TEST WAS USED FROM A SECOND BOX, WHICH ALSO PROVIDED A NEGATIVE RESULT. THE SAME SAMPLE WAS USED FOR ALL FOUR TESTS. A CONFIRMATORY BLOOD HCG WAS PERFORMED WHICH PROVIDED A NEGATIVE RESULT. EXACT RESULT AND METHODOLOGY NOT PROVIDED. PATIENT WAS INSTRUCTED TO STAY WELL HYDRATED TO AVOID DEHYDRATION. THE CUSTOMER REPORTED THAT BASED ON EVALUATION, NO OTHER TREATMENT WAS REQUIRED; SUPPORTIVE CARE ONLY. LATER THAT DAY, AN OUTSIDE PROVIDER DIAGNOSED THE PATIENT WITH A RUPTURED OVARIAN CYST. THE PATIENT IS PRESENTLY STABLE. THIS DEVICE IS NOT INTENDED TO DIAGNOSE WHETHER A PATIENT HAS AN OVARIAN CYST. THE CLINICIAN'S CARE IS BASED ON A FULL EVALUATION AND NOT AS A RESULT OF THE HCG TEST. THE RUPTURING OF THE CYST IS NOT RELATED TO THE FALSE POSITIVE HCG RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12200408 ↗
• MalfunctionJul 16, 2021False Positive Result; False Positive Result

  UNSPECIFIED DATE: FALSE POSITIVE RESULT OBTAINED ON THE HCG ONE STEP PREGNANCY TEST DEVICE. LINE WAS A WEAK POSITIVE, SO THE SAMPLE WAS SENT TO THE LAB FOR A CONFIRMATORY HCG QUANT. CONFIRMATORY QUANT PROVIDED A NEGATIVE RESULT; EXACT RESULT NOT PROVIDED. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED. CUSTOMER UNRESPONSIVE.

  Patient problems: Insufficient Information

  MAUDE report 12180436 ↗
• MalfunctionApr 16, 2020False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE URINE RESULT AFTER PERFORMING AN HCG TEST WITH A PATIENT ON (B)(6) 2020. THE PATIENT ALLEGEDLY PERFORMED 8 PREGNANCY TESTS AT HOME WHICH WERE POSITIVE. A SERUM SAMPLE WAS DRAWN AND THE RESULT WAS 224 IU/ML. A CLINICIAN RETESTED THE URINE SPECIMEN AND OBSERVED THAT THE TEST RESULT WAS POSITIVE. THE CONTROLS PERFORMED AS EXPECTED, TECHNIQUE AND PROCEDURE WERE FOLLOWED. SUBSEQUENTLY, THE CARE COORDINATOR OF THE MEDICAL CENTER RAN THE SAME URINE SAMPLE ON 10 HCG TESTS WITH POSITIVE RESULTS. THERE WAS NO TREATMENT, PROCEDURE OR MEDICATION CHANGED FOR THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9968358 ↗
• 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 ↗

Other Alere San Diego, Inc. products

• Cholestech LDX5 models · 2 reports · 3 recalls
• Alere Cholestech LDX6 models · 1 reports · 1 recall