i-STAT 03P90-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 474 adverse event reports that list this exact device (DI 10054749000187), received between Mar 24, 2017 and Sep 22, 2026 — classified as 474 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (353 reports).

5 other recalls cover devices cleared under the same FDA submission (K031739); they may or may not involve this specific model.

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

Recent adverse event reports

The 25 most recent of 474 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50859844 ↗
• MalfunctionJun 25, 2025False Positive Result; False Positive Result

  ON (B)(6) 2025, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED DISCREPANT FALSE NEGATIVE RESULT OF 0.01 NG/ML ON A 78-YEAR-OLD MALE PATIENT PRESENTED WITH SUBSTERNAL CHEST PRESSURE, CHEST PAIN ON ARRIVAL (RATED 8/10). RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD: DATE: COLLECTED TESTED: RESULTS: SAMPLE: I-STAT , ON (B)(6) 2025 , 02:49 , 03:00, 0.01 NG/ML , 1, BECKMANN COULTER, ON (B)(6) 2025 , 02:49 , 02:57, 0.55 NG/ML, 1, BECKMANN COULTER , ON (B)(6) 2025 , 21:16 , 21:30, 0.44 NG/ML , 2. ON (B)(6) 2025 THE CUSTOMER STATED THAT THE FINAL DIAGNOSIS WAS NON-OBSTRUCTIVE CAD, AND RESULTS OF AN ANGIOGRAM AND EKG, IT WAS DETERMINED THAT THE PATIENT DID NOT SUFFER AN MI. ON (B)(6) 2025 THE CUSTOMER REPORTED THAT THE PATIENT'S FINAL DIAGNOSIS WAS NON-ST ELEVATION (NSTEMI) MYOCARDIAL INFARCTION. THERE WAS NO CHANGES TO INITIAL DIAGNOSIS, ANGIOGRAM, NOR EKG RESULTS. THE INVESTIGATION WAS COMPLETED ON 29-MAY-2025 AND NO DEFICIENCY HAS BEEN IDENTIFIED FOR CTNI CARTRIDGE LOT S24331A. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTED THAT PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY. THERE IS

  Patient problems: Chest Pain; Ischemia; Myocardial Infarction

  MAUDE report 22327811 ↗
• MalfunctionFeb 11, 2025False Positive Result; False Positive Result

  ON 24-JAN-2025, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED DESCREPANT FALSE POSITIVE RESULT OF 0.24 NG/ML ON A PATIENT. THERE WAS NO PATIENT INFORMATION, NOR DETAILS SURROUNDING THE EVENT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD: DATE: TESTED: RESULT: I-STAT, (B)(6) 2025, 12:36, 0.28 NG/ML. VITROS 7600, NI. NI, <0.012 NG/ML. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTED THAT PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY. THERE IS NO EVIDENCE THE PATEINT SUFFERED AN MI. THE INVESTIGATION IS UNDERWAY. PER I-STAT SYSTEM MANUAL: ART: 715595-00V, REPORTABLE RANGE: 0.00 - 50.00, REFERENCE RANGE: 0.00 - 0.03 (REPRESENTS THE 0 TO 97.5% RANGE OF RESULTS), REFERENCE RANGE: 0.00 - 0.08 (REPRESENTS THE 0 TO 99% RANGE OF RESULTS).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21355413 ↗
• MalfunctionMar 26, 2024False Positive Result; False Positive Result

  NA.

  Patient problems: Chest Pain; Myocarditis

  MAUDE report 18979532 ↗
• MalfunctionFeb 20, 2024False Negative Result; False Negative Result

  ON 29-JAN-2024, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED A FALSE NEGATIVE RESULT OF 0.05 A 40 YEAR OLD FEMALE PATIENT WITH SHORTNESS OF BREATH. CUSTOMER STATES THAT THE ALTERNATE METHOD WAS POSITIVE. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. METHOD DATE TESTED RESULT SAMPLE I-STAT (B)(6) 2024 6:34 AM 0.05 NG/ML A, WB FROM LITH HEP DXI (B)(6) 2024 7:07 AM 0.123 NG/ML B, PLASMA FROM LITH HEP COLLECTION TIMES WERE NOT PROVIDED AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTED THAT PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY. THERE IS NO EVIDENCE THE PATEINT SUFFERED AN MI. IT IS SUSPECTED THAT THE CUSTOMER IS COMPARING ACROSS PLATFORMS IN THIS CASE WHICH IS NOT RECOMMENDED . THE CUSTOMER IS COMPARING THE I-STAT TROPONIN I AGAINST TROPONIN T AND THE RESULTS OF DIFFERENT TROPONIN ASSAYS ARE NOT GENERALLY COMPARABLE: CTNI AND CTNT ARE DISTINCT MOLECULES AND RESULTS ARE NOT INTERCHANGEABLE, NOR COMPARABLE. IN ADDITION, SIGNIFICANT VARIATION IN ABSOLUTE TROPONIN VALUES MAY BE OBSERVED FOR A G

  Patient problems: Decreased Respiratory Rate

  MAUDE report 18740749 ↗
• MalfunctionFeb 20, 2024False Positive Result; False Positive Result

  ON 14-FEB-2024, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED A FALSE POSITIVE RESULT OF 0.38 ON A 65 YEAR OLD FEMALE PATIENT WITH LEFT SHOULDER PAIN. MI RULED OUT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD; DATE; COLLECTED; TESTED; RESULT; SAMPLE. I-STAT, (B)(6) 2024, 15:08, 15:09 , 0.38 NG/ML & A. I-STAT, (B)(6) 2024, 15:08, NI, 0.00 NG/ML & A. I-STAT, (B)(6) 2024, 17:38, 17:56, 0.00 NG/ML & B. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTED THAT PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY. THERE IS NO EVIDENCE THE PATEINT SUFFERED AN MI. THE INVESTIGATION IS UNDERWAY. PER I-STAT SYSTEM MANUAL: ART: 715595-00V. REPORTABLE RANGE: 0.00 - 50.00. REFERENCE RANGE: 0.00 - 0.03 (REPRESENTS THE 0 TO 97.5% RANGE OF RESULTS). REFERENCE RANGE: 0.00 - 0.08 (REPRESENTS THE 0 TO 99% RANGE OF RESULTS).

  Patient problems: Limb Pain

  MAUDE report 18740748 ↗
• MalfunctionFeb 20, 2024False Positive Result; False Positive Result

  ON 15-FEB-2024, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED A FALSE POSITIVE RESULT OF 0.10 ON A 51 YEAR OLD FEMALE PATIENT WITH NON- CARDIAC CHEST PAIN. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD DATE COLLECTED TESTED RESULTS I-STAT (B)(6) 2024 12:06 12.15 0.10 I-STAT (B)(6) 2024 13:57 14:00 0.00 I-STAT (B)(6) 2024 13:57 14:46 0.00 AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTED THAT PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY. THERE IS NO EVIDENCE THE PATEINT SUFFERED AN MI. THE INVESTIGATION IS UNDERWAY. PER I-STAT SYSTEM MANUAL: ART: 715595-00V REPORTABLE RANGE: 0.00 - 50.00 REFERENCE RANGE: 0.00 - 0.03 (REPRESENTS THE 0 TO 97.5% RANGE OF RESULTS) REFERENCE RANGE: 0.00 - 0.08 (REPRESENTS THE 0 TO 99% RANGE OF RESULTS)

  Patient problems: Chest Pain

  MAUDE report 18740745 ↗
• MalfunctionFeb 13, 2024False Positive Result; False Positive Result

  ON 07-FEB-2024, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED A FALSE POSITIVE DISCREPANT RESULT OF 0.16 NG/L ON A PATIENT. THERE WAS NO PATIENT INFORMATION AT THE TIME OF THIS REPORT. METHOD; DATE & RESULTS. I-STAT, 10:09 & 0.16. I-STAT, 10:23 & 0.02. I-STAT, 10:53 & 0.00. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTED THAT PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY. THERE IS NO EVIDENCE THE PATEINT SUFFERED AN MI. THE INVESTIGATION IS UNDERWAY. PER I-STAT SYSTEM MANUAL: ART: 715595-00V. REPORTABLE RANGE: 0.00 - 50.00. REFERENCE RANGE: 0.00 - 0.03 (REPRESENTS THE 0 TO 97.5% RANGE OF RESULTS). REFERENCE RANGE: 0.00 - 0.08 (REPRESENTS THE 0 TO 99% RANGE OF RESULTS).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18696297 ↗
• MalfunctionFeb 13, 2024False Positive Result; False Positive Result

  ON 07-FEB-2024, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED FALSE POSITIVE DISCREPANT RESULTS OF 6.50 & 6.01 NG/L ON A PATIENT. THE CUSTOMER STATED THAT THE PATIENT HAD NO CARDIAC SYMPTOMS AND WAS DISCHARGED AS SUCH. THERE WAS NO PATIENT INFORMATION AT THE TIME OF THIS REPORT. METHOD; DATE & RESULTS. I-STAT, 16:19 & 6.50. I-STAT, 10:39 & 6.01. DATE, TEST/COLLECTION TIMES WERE NOT PROVIDED. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTED THAT PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY. THERE IS NO EVIDENCE THE PATEINT SUFFERED AN MI. THE INVESTIGATION IS UNDERWAY. PER I-STAT SYSTEM MANUAL: ART: 715595-00V. REPORTABLE RANGE: 0.00 - 50.00. REFERENCE RANGE: 0.00 - 0.03 (REPRESENTS THE 0 TO 97.5% RANGE OF RESULTS). REFERENCE RANGE: 0.00 - 0.08 (REPRESENTS THE 0 TO 99% RANGE OF RESULTS).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18696296 ↗
• MalfunctionFeb 13, 2024False Positive Result; False Positive Result

  ON 07-FEB-2024, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED A FALSE POSITIVE DISCREPANT RESULT OF 0.10 NG/L ON A PATIENT. THERE WAS NO PATIENT INFORMATION AT THE TIME OF THIS REPORT. METHOD; DATE & RESULTS. I-STAT, 14:23 & 0.10. I-STAT, 15:47 & 0.00. I-STAT, 16:00 & 0.00. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTED THAT PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY. THERE IS NO EVIDENCE THE PATEINT SUFFERED AN MI. THE INVESTIGATION IS UNDERWAY. PER I-STAT SYSTEM MANUAL: ART: 715595-00V. REPORTABLE RANGE: 0.00 - 50.00. REFERENCE RANGE: 0.00 - 0.03 (REPRESENTS THE 0 TO 97.5% RANGE OF RESULTS). REFERENCE RANGE: 0.00 - 0.08 (REPRESENTS THE 0 TO 99% RANGE OF RESULTS).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18696295 ↗
• MalfunctionJan 30, 2024False Positive Result; False Positive Result

  ON (B)(6) 2024, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED A FALSE POSITIVE DISCREPANT RESULT OF 0.1 NG/L ON A PATIENT. THERE WAS NO PATIENT INFORMATION AT THE TIME OF THIS REPORT. METHOD, DATE, TESTED, RESULT , TYPE, SAMPLE. I-STAT, (B)(6) 2024, 1247, 0.1 NG/ML, WHOLE BLOOD, A. VITROS, (B)(6) 2024, 1259 <0.012 NG/ML, SERUM, B. VITROS, (B)(6) 2024 1348 <0.012 NG/ML, PLASMA, A. I-STAT#, (B)(6)2024, NI, 0.00, WHOLE BLOOD, B. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTED THAT PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY. THERE IS NO EVIDENCE THE PATIENT SUFFERED AN MI. THE INVESTIGATION IS UNDERWAY. PER I-STAT SYSTEM MANUAL: ART: 715595-00V. REPORTABLE RANGE: 0.00 - 50.00. REFERENCE RANGE: 0.00 - 0.03 (REPRESENTS THE 0 TO 97.5% RANGE OF RESULTS). REFERENCE RANGE: 0.00 - 0.08 (REPRESENTS THE 0 TO 99% RANGE OF RESULTS).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18605865 ↗
• MalfunctionJan 16, 2024False Positive Result; False Positive Result

  ON (B)(6) 2024, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED A FALSE POSITIVE DISCREPANT RESULT OF (B)(6) YEAR OLD MALE PATIENT ADMITTED FOR CHEST PAIN . THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. CUSTOMER STATES THE PATIENT HAD A BLOOD CLOT EVACUATED FEW DAYS BEFORE, CAME WITH CHEST PAIN, AFTER ANGIOGRAM PATIENT WAS RELEASED DUE TO NO ABNORMALITIES IN ANGIOGRAM AND ECO METHOD DATE TESTED CTNI I-STAT (B)(6) 2024 08.25 2.46 NG/ML 1ST ECG (RESULTS WAS NORMAL) 2ND I-STAT (POSITIVE) 3RD LABORATORY AT NAWALOKA HOSPITAL(NEGATIVE) 4TH ANGIOGRAM - NORMAL AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTED THAT PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY. THERE IS NO EVIDENCE THE PATEINT SUFFERED AN MI. THE INVESTIGATION IS UNDERWAY. PER I-STAT SYSTEM MANUAL: ART: (B)(6) RANGE OF RESULTS).

  Patient problems: Chest Pain

  MAUDE report 18521411 ↗
• MalfunctionJan 3, 2024False Positive Result; False Positive Result

  ON (B)(6) 2023, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED A FALSE POSITIVE DISCREPANT RESULT OF 0.13 NG/L ON A 52 YEAR OLD FEMALE PATIENT . THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD DATE TESTED RESULT SAMPLE TYPE I-STAT 09-AUG-2023 1624 0.13NG/ML WB VITROS 5600 09-AUG-2023 1624 0.012NG/ML PLASMA AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTED THAT PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY. THERE IS NO EVIDENCE THE PATIENT SUFFERED AN MI. THE INVESTIGATION IS UNDERWAY. PER I-STAT SYSTEM MANUAL: ART: 715595-00V REPORTABLE RANGE: 0.00 - 50.00 REFERENCE RANGE: 0.00 - 0.03 (REPRESENTS THE 0 TO (B)(4) RANGE OF RESULTS). REFERENCE RANGE: 0.00 - 0.08 (REPRESENTS THE 0 TO (B)(4) RANGE OF RESULTS).

  Patient problems: Abdominal Pain

  MAUDE report 18436141 ↗
• MalfunctionJan 3, 2024False Positive Result; False Positive Result

  ON (B)(6) 2023, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED A FALSE POSITIVE DISCREPANT RESULT OF 0.09 NG/L ON A 74 YEAR OLD MALE PATIENT . THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD DATE COLLECT/TESTED RESULT SAMPLE TYPE. I-STAT (B)(6) 2023 13:48 0.09NG/ML WB. VITROS 5600 (B)(6) 2023 13:48 <0.012NG/ML PLASMA. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTED THAT PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY. THERE IS NO EVIDENCE THE PATEINT SUFFERED AN MI. THE INVESTIGATION IS UNDERWAY. PER I-STAT SYSTEM MANUAL: ART: 715595-00V. REPORTABLE RANGE: 0.00 - 50.00. REFERENCE RANGE: 0.00 - 0.03 (REPRESENTS THE 0 TO 97.5% RANGE OF RESULTS). REFERENCE RANGE: 0.00 - 0.08 (REPRESENTS THE 0 TO 99% RANGE OF RESULTS).

  Patient problems: Pneumothorax

  MAUDE report 18436088 ↗
• MalfunctionJan 3, 2024False Positive Result; False Positive Result

  ON (B)(6) 2023, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED A FALSE POSITIVE DISCREPANT RESULT OF 0.12 NG/L ON A 31 YEAR OLD FEMALE PATIENT . THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD DATE COLLECT/TESTED RESULT SAMPLE TYPE I-STAT (B)(6)2023 10:34 0.12NG/ML WB VITROS 5600 (B)(6)2023 10:34 <0.012NG/ML PLASMA AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTED THAT PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY. THERE IS NO EVIDENCE THE PATIENT SUFFERED AN MI. THE INVESTIGATION IS UNDERWAY. PER I-STAT SYSTEM MANUAL: ART: 715595-00V. REPORTABLE RANGE: 0.00 - 50.00. REFERENCE RANGE: 0.00 - 0.03 (REPRESENTS THE(B)(4) RANGE OF RESULTS). REFERENCE RANGE: 0.00 - 0.08 (REPRESENTS THE (B)(4) RANGE OF RESULTS).

  Patient problems: Skin Disorders

  MAUDE report 18436086 ↗
• MalfunctionJan 3, 2024False Positive Result; False Positive Result

  ON 19-DEC-2023, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED A FALSE POSITIVE DISCREPANT RESULT OF 0.19 NG/L ON A (B)(6) OLD FEMALE PATIENT . THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD DATE TESTED RESULT SAMPLE TYPE I-STAT 23-SEP-2023 11:28 0.19NG/ML WB VITROS 5600 23-SEP-2023 NI <0.012NG/ML PLASMA. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTED THAT PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY. THERE IS NO EVIDENCE THE PATEINT SUFFERED AN MI. THE INVESTIGATION IS UNDERWAY. PER I-STAT SYSTEM MANUAL: ART: 715595-00V REPORTABLE RANGE: 0.00 - 50.00 REFERENCE RANGE: 0.00 - 0.03 (REPRESENTS THE 0 TO 97.5% RANGE OF RESULTS). REFERENCE RANGE: 0.00 - 0.08 (REPRESENTS THE 0 TO 99% RANGE OF RESULTS).

  Patient problems: Dyspnea

  MAUDE report 18436072 ↗
• MalfunctionDec 19, 2023False Positive Result; False Positive Result

  NA.

  Patient problems: Chest Pain; Dyspnea

  MAUDE report 18354751 ↗
• MalfunctionNov 27, 2023False Positive Result; False Positive Result

  ON 24-NOV-2023, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED A FALSE POSITIVE DISCREPANT RESULT OF 0.16 NG/L ON A PATIENT WITH ELEVATED HEART RATE IN 150S.. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD DATE COLLECTED TESTED RESULT SAMPLE DXI (B)(6) 2023, 12:09 , 12:42 , 0.03 NG/ML, A. I-STAT (B)(6) 2023, 13:50 , 13:59 , 0.16 NG/ML , B. DXI (B)(6) 2023, 13:50 , 14:28 , 0.03 NG/ML , B SPUN SAMPLE. CRITICAL CUTOFF: I-STAT AND LAB: > 0.06 . DXI BECKMAN > 0.03. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTED THAT PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY. THERE IS NO EVIDENCE THE PATEINT SUFFERED AN MI. THE INVESTIGATION IS UNDERWAY. PER I-STAT SYSTEM MANUAL: ART: 715595-00V. REPORTABLE RANGE: 0.00 - 50.00. REFERENCE RANGE: 0.00 - 0.03 (REPRESENTS THE 0 TO 97.5% RANGE OF RESULTS). REFERENCE RANGE: 0.00 - 0.08 (REPRESENTS THE 0 TO 99% RANGE OF RESULTS).

  Patient problems: Tachycardia

  MAUDE report 18210214 ↗
• MalfunctionNov 20, 2023False Positive Result; False Positive Result

  ON 14-NOV-2023, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED A FALSE POSITIVE DISCREPANT RESULT OF 0.05 NG/L ON A PATIENT WITH CHEST PAIN. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD DATE COLLECTED TESTED RESULTS(NG/ML) I-STAT 13-NOV-23 10:17 IMMEDIATELY 0.05 (POSITIVE) SAMPLE 1 I-STAT 13-NOV-23 10:17 10:30 0.00 (NEGATIVE) SAMPLE 1 REPEAT I-STAT 13-NOV-23 10:30 IMMEDIATELY 0.00 (NEGATIVE) SAMPLE 2 I-STAT 13-NOV-23 10:30 10:40 0.00 (NEGATIVE) SAMPLE 2 REPEAT AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTED THAT PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY. THERE IS NO EVIDENCE THE PATEINT SUFFERED AN MI. THE INVESTIGATION IS UNDERWAY. PER I-STAT SYSTEM MANUAL: ART: 715595-00V REPORTABLE RANGE: 0.00 - 50.00 REFERENCE RANGE: 0.00 - 0.03 (REPRESENTS THE 0 TO 97.5% RANGE OF RESULTS) REFERENCE RANGE: 0.00 - 0.08 (REPRESENTS THE 0 TO 99% RANGE OF RESULTS)

  Patient problems: Chest Pain

  MAUDE report 18175760 ↗
• MalfunctionNov 8, 2023False Positive Result; False Positive Result

  ON (B)(6) 2023, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED A FALSE POSITIVE DISCREPANT RESULT OF 0.26 NG/L ON A PATIENT. THERE WAS NO PATIENT INFORMATION AT THE TIME OF THIS REPORT. METHOD DATE COLLECTED TESTED RESULTS SAMPLE: I-STAT (B)(6) 2023 23:30 23:46 0.26 UG/L A. LAB (B)(6) 2023 23:30 00:26 8 NG/L A. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTED THAT PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY. THERE IS NO EVIDENCE THE PATEINT SUFFERED AN MI. THE INVESTIGATION IS UNDERWAY. PER I-STAT SYSTEM MANUAL: ART: 715595-00V. REPORTABLE RANGE: 0.00 - 50.00. REFERENCE RANGE: 0.00 - 0.03 (REPRESENTS THE 0 TO 97.5% RANGE OF RESULTS). REFERENCE RANGE: 0.00 - 0.08 (REPRESENTS THE 0 TO 99% RANGE OF RESULTS).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18091753 ↗
• MalfunctionOct 31, 2023False Positive Result; False Positive Result

  ON 17-OCT-2023, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED A FALSE POSITIVE DISCREPANT RESULT ON A PATIENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD : RESULT : SAMPLE: I-STAT , NO RESULT PROVIDED , NI. I-STAT , <0.02 NG/ML , B. NO TEST/COLECT TIMES PROVIDED. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTED THAT PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY. THERE IS NO EVIDENCE THE PATEINT SUFFERED AN MI. THE INVESTIGATION IS UNDERWAY. PER I-STAT SYSTEM MANUAL: ART: 715595-00V. REPORTABLE RANGE: 0.00 - 50.00. REFERENCE RANGE: 0.00 - 0.03 (REPRESENTS THE 0 TO 97.5% RANGE OF RESULTS). REFERENCE RANGE: 0.00 - 0.08 (REPRESENTS THE 0 TO 99% RANGE OF RESULTS).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18038119 ↗
• MalfunctionOct 23, 2023False Positive Result; False Positive Result

  ON (B)(6) 2023, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED A FALSE POSITIVE DISCREPANT RESULT OF 0.15 NG/L ON A PATIENT. THERE WAS NO PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD: I-STAT; DATE: (B)(6) 2023 ; TESTED: 13:05; RESULT: 0.15 UG/L; SAMPLE: A. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTED THAT PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY. THERE IS NO EVIDENCE THE PATEINT SUFFERED AN MI. THE INVESTIGATION IS UNDERWAY. PER I-STAT SYSTEM MANUAL: ART: 715595-00V. REPORTABLE RANGE: 0.00 - 50.00. REFERENCE RANGE: 0.00 - 0.03 (REPRESENTS THE 0 TO 97.5% RANGE OF RESULTS). REFERENCE RANGE: 0.00 - 0.08 (REPRESENTS THE 0 TO 99% RANGE OF RESULTS).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17993244 ↗
• MalfunctionOct 23, 2023False Positive Result; False Positive Result

  ON (B)(6) 2023, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED A FALSE POSITIVE DISCREPANT RESULT OF 160 NG/L ON A PATIENT. THERE WAS NO PATIENT INFORMATION AT THE TIME OF THIS REPORT. METHOD, DATE, TESTED, RESULTS, SAMPLE: I-STAT , (B)(6) 2023, 08:00 ,160 NG/L ,HEPARINIZED WHOLE BLOOD .ALINITY LAB, (B)(6) 2023 , 11:30, <5.1 NG/L , HEPARIN PLASMA. I-STAT , (B)(6) 2023 , 12:00, <30 NG/L , HEPARINIZED WHOLE BLOOD. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTED THAT PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY. THERE IS NO EVIDENCE THE PATIENT SUFFERED AN MI. THE INVESTIGATION IS UNDERWAY. PER I-STAT SYSTEM MANUAL: ART: 715595-00V. REPORTABLE RANGE: 0.00 - 50.00. REFERENCE RANGE: 0.00 - 0.03 (REPRESENTS THE 0 TO 97.5% RANGE OF RESULTS). REFERENCE RANGE: 0.00 - 0.08 (REPRESENTS THE 0 TO 99% RANGE OF RESULTS).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17993243 ↗
• MalfunctionOct 18, 2023False Negative Result; False Negative Result

  NA.

  Patient problems: Respiratory Insufficiency

  MAUDE report 17956841 ↗
• MalfunctionOct 11, 2023False Negative Result; False Negative Result

  ON 10-OCT-2023, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED A FALSE NEGATIVE DISCREPANT RESULT OF 0.00 NG/ML ON A 72 YEAR OLD FEMALE PATIENT WITH STROKE-LIKE SYMPTOMS, LEFT SIDED FACIAL DROOP, ARM AND LEG NUMBNESS/WEAKNESS. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD: I-STAT; DATE: (B)(6) 2023; COLLECTED: 20:04; TESTED: 20:04; RESULT: 0.00; SAMPLE: VENOUS #1. METHOD: ARCHITECT; DATE: (B)(6) 2023; COLLECTED: 20:04; TESTED: 21:00; RESULT (NG/ML): 0.182; SAMPLE: VENOUS #1. METHOD: ARCHITECT; DATE: (B)(6) 2023; COLLECTED: 00:13; TESTED: 01:05; RESULT: (NG/ML): 0.174; SAMPLE: VENOUS #2. METHOD: ARCHITECT; DATE: (B)(6) 2023; COLLECTED: 08:40; TESTED: 09:57; RESULT (NG/ML): 0.167; SAMPLE: VENOUS #3. POSITIVE CUT-OFF VALUE FOR I-STAT TROPONIN TEST: 0.08NG/ML. POSITIVE CUT-OFF VALUE FOR ARCHITECT: 0.030 NG/ML. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTED THAT PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY. THERE IS NO EVIDENCE THE PATEINT SUFF

  Patient problems: Encephalopathy; Facial Paralysis; Intracranial Hemorrhage; Stroke/CVA

  MAUDE report 17911854 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K031739. One submission often covers many models, so check the product and lot details in each record.

• Z-0761-2020 · Oct 16, 2019 · Terminated
  i-STAT cTnI cartridge
• Z-0716-2013 · Nov 1, 2012 · Terminated
  Abbott Point of Care i-Stat cTnI cartridge. The i-Stat cardiac troponin I (cTnI) test is an in vitro diagnostic test for the quantitive measurement of cardiac troponin I (cTnI) in
• Z-2237-2012 · Mar 7, 2012 · Terminated
  i-STAT cTnI cartridges Product Usage: The i-STAT cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or pla
• Z-2169-2012 · Feb 1, 2012 · Terminated
  i-Stat cTnl cartridges Abbott Point of Care Inc. The i-Stat cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole b
• Z-0180-2012 · Sep 29, 2011 · Terminated
  i-Stat cTnI cartridges Is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples.