i-STAT 09P31-25Recalls & reported problems
Abbott Point Of Care Inc. · CARTRIDGE, CHEM8+ · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Abbott i-STAT cartridge is a test cartridge that measures several blood chemistry levels. Its 419 reports mostly describe incorrect or imprecise results, such as conflicting potassium, creatinine and hemoglobin values compared with other tests. The reports include no deaths and no injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 423
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 423 adverse event reports that list this exact device (DI 10054749001917), received between Mar 24, 2017 and Sep 2, 2026 — classified as 423 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (409 reports).
3 other recalls cover devices cleared under the same FDA submission (K053110); 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings409
- False Positive Result9
- False Negative Result4
- Incorrect Or Inadequate Test Results1
Patient problems
- No Information148
- No Code Available34
- Abdominal Pain29
- No Clinical Signs, Symptoms or Conditions27
- Pain22
- Chest Pain21
- Nausea19
- High Blood Pressure/ Hypertension18
Recent adverse event reports
The 25 most recent of 423 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 2, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50563788 ↗MalfunctionSep 2, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50563787 ↗MalfunctionSep 2, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50563786 ↗MalfunctionSep 2, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50563785 ↗MalfunctionMar 19, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
MalfunctionFeb 26, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ON 15-FEB-2024, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGE THAT YIELDED DISCREPANT CREA RESULTS ON AN 82 YEAR OLD FEMALE PATIENT WITH ABDOMINAL PAIN. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD; DATE; COLLECTED; TESTED RESULT (UNITS) & SAMPLE. I-STAT, (B)(6) 2024, 1320, 1323, 360 UMOL/L & A. PICCOLO, (B)(6) 2024, 1320, 1323, 62 UMOL/L & A. I-STAT, (B)(6) 2024, 1350, 1354, 346 UMOL/L & B. PICCOL0, (B)(6) 2024, 1350, 1354, 68 UMOL/L & B. LAB, (B)(6) 2024, 1350, 1536, 74 UMOL/L & 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. THE INVESTIGATION IS UNDERWAY.
Patient problems: Abdominal Pain
MAUDE report 18777806 ↗MalfunctionJan 30, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ON 24-JAN-2024, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGE THAT YIELDED A DISCREPANT BUN RESULT ON A PATIENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD DATE TESTED RESULT SAMPLE I-STAT (B)(6) 2024 2:52 >140 MG/DL A CATALYST (B)(6) 2024 3:06 101 MG/DL 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. THE INVESTIGATION IS UNDERWAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18605501 ↗MalfunctionJan 10, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ON 04-JAN-2024, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGE THAT YIELDED A DISCREPANT POTASSIUM RESULT OF 65 YEAR OLD MALE PATIENT SEEN FOR A GENERAL CHECK-UP.. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD DATE COLLECTED TESTED RESULTS SAMPLE I-STAT (B)(6) 2024 09:00 09:08 7.4 A I-STAT (B)(6) 2024 09:00 09:17 >9.0 A >5.5 IS CRITICAL RESULT FOR K. 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. THE INVESTIGATION IS UNDERWAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18482975 ↗MalfunctionJan 3, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ON (B)(6) 2023, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGE THAT YIELDED A DISCREPANT HEMOGLOBIN RESULT OF 78 ON A 72 YEAR OLD FEMALE PATIENT WITH A SUBARACHNOID BLEED. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD: RESULT: I-STAT 1, 78, LAB, 120 . COLLECTION/TEST TIMES, LAB METHOD 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. THE INVESTIGATION IS UNDERWAY.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 18436059 ↗MalfunctionDec 29, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ON (B)(6) 2023, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGE THAT YIELDED A DISCREPANT POTASSIUM RESULT OF >9.0 MMOL/L ON A PATIENT. THERE WAS NO PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD, RESULT, SAMPLE: I-STAT >9.0, MMOL/L, A; I-STAT, 4.2 MMOL/L, A; LAB, 4.2, MMOL/L, NI. COLLECTION/TEST TIMES, LAB METHOD 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. THE INVESTIGATION IS UNDERWAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18418054 ↗MalfunctionDec 5, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
MalfunctionOct 18, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ON (B)(6) 2023, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGE THAT YIELDED DISCREPANT POTASSIUM RESULTS ON A 44 YEAR OLD FEMALE PATIENT DIAGNOSED WITH A RUPTURED AORTIC ROOT ANEURYSM. ACUTE LIVER FAILURE; RENAL FAILURE; COAGULOPATHY; SEVERE METABOLIC ACIDOSIS AND HYPERLACTATAEMIA. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD: I-STAT; DATE: (B)(6) 2023; TESTED: 17:05; RESULT: >9 MMOL/L; SAMPLE: A. METHOD: I-STAT ; DATE: (B)(6) 2023 ; TESTED: 17:16; RESULT: >9 MMOL/L; SAMPLE: B. METHOD: LAB ABG; DATE: NI; TESTED: NI; RESULT: 5.1; SAMPLE: NI. -COLLECTION TIMES NOT REPORTED. -LAB TEST/COLLECT/SAMPLE INFOMATION NOT REPORTED. 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. THE INVESTIGATION IS UNDERWAY.
Patient problems: Aneurysm; Liver Failure; Renal Failure; Respiratory Acidosis
MAUDE report 17956848 ↗MalfunctionOct 3, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ON 27-SEP-2023, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGE THAT YIELDED A DISCREPANT POTASSIUM RESULT OF >9 MMOL/L ON A PATIENT. THERE WAS NO PATIENT INFORMATION AT THE TIME OF THIS REPORT. METHOD; DATE ; TESTED; RESULT; SAMPLE; I-STAT (B)(6) 2023 14:59 >9 MMOL/L A. LAB (B)(6) 2023 15:30 4.30 MMOL/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. THE INVESTIGATION IS UNDERWAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17860455 ↗MalfunctionSep 13, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ON (B)(6) 2023, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGE THAT YIELDED DISCREPANT SODIUM RESULTS ON A PATIENT DIAGNOSED WITH ADDISON'S CRISIS. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD: I-STAT, DATE: (B)(6) 2023, COLLECTED: 16:15, TESTED: 16:19, RESULTS: 111, SAMPLE: 1. METHOD: I-STAT, DATE: (B)(6) 2023, COLLECTED: 16:15, TESTED: 18:15, RESULTS: 130, SAMPLE: 1. METHOD: I-STAT, DATE: (B)(6) 2023, COLLECTED: 17:45, TESTED: 17:47, RESULTS: 131, SAMPLE: 2. COBAS, DATE: (B)(6) 2023, COLLECTED: 17:45, TESTED: 18:00, RESULTS: 131, SAMPLE: 2. 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. THE INVESTIGATION IS UNDERWAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17740210 ↗MalfunctionAug 30, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ON (B)(6) 2023, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGE THAT YIELDED DISCREPANT POTASSIUM RESULTS OF 9 MMOL/L ON A 27 YEAR OLD MALE PATIENT WITH WEAK LIMBS AND WAS UNABLE TO WALK THAT DAY. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD K. I-STAT, 9 MMOL/L. LAB , 2.8 MMOL/L. TEST/COLLECTION TIMES REQUESTED BUT NOT PROVIDED. THE CUSTOMER SAID THAT A PATIENT HAD WEAK LIMBS AND WAS UNABLE TO WALK THAT DAY, WHICH REQUIRED TESTING OF ELECTROLYTES. ONCE THE I-STAT CHEM8+ CARTRIDGE WAS USED FOR TESTING, THE K RESULTS DID NOT MATCH THE PATIENT'S CONDITION OR THE ECG RESULTS. THE CUSTOMER STATED THAT THE SAMPLE COLLECTION MAY HAVE BEEN EDTA. THE MEDICAL STAFF HAD DOUBTS, SO THEY SENT THE SAMPLE TO THE LABORATORY AND WAITED FOR THE TEST RESULTS FROM THE LABORATORY. A REPEAT ON AN ALTERNATE METHOD YIELDED A RESULT THAT WAS ACCEPTABLE ON A NEW SAMPLE. ON-SITE OBSERVATION FOUND THAT THE DEPARTMENT MAY HAVE MISTAKENLY USED BLOOD COLLECTION TUBES WITH EDTA ANTICOAGULANT THAT DAY WHEN BLOOD WAS DRAWN, RESULTING IN EXCESSIVELY HIGH POTASSIUM. ON-SITE TRAINING WAS CONDU
Patient problems: Muscle Weakness/Atrophy
MAUDE report 17650543 ↗MalfunctionAug 1, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
MalfunctionMay 3, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
MalfunctionApr 26, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ON (B)(6) 2023, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGE THAT YIELDED DISCREPANT HEMATOCRIT RESULT ON A PATIENT. THERE WAS NO PATIENT INFORMATION, NO RESULTS, NO PRODUCT INFORMATION, NO TEST/COLLECTION TIMES AND DATE, NOR DETAILS SURROUNDING THE EVENT AT THE TIME OF THIS REPORT. THE CUSTOMER STATED THAT THEY ARE WRITING UP AN M&M CASE WHERE A PATIENT WAS OVER TRANSFUSED AFTER AN I-STAT READING OF HB 54 (WHICH WAS LATER FOUND TO BE FALSE). IT IS UNCLEAR AND UNCONFIRMED IF THE PATIENT IS RELATED TO THE COMPLAINT. INFORMATION HAS BEEN REQUESTED MULTIPLE TIMES BUT TO NO AVAIL. THERE HAS BEEN NO RESPONSE. 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. THE INVESTIGATION IS UNDERWAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16814894 ↗MalfunctionApr 19, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ON (B)(6) 2023, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGE THAT YIELDED DISCREPANT HEMATOCRIT RESULT ON A PATIENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. THE CUSTOMER STATED THAT LAST WEEK A PATIENT TESTED HIGH HCT ON I-STAT ANALYZER 74%. PATIENT WAS NOT ACTIVELY BLEEDING AND THERE WAS NO BLOOD TRANSFUSION. SINCE IT WAS TOO HIGH THEY RAN MANUAL AND THAT WAS 42%. INFORMATION HAS BEEN REQUESTED, HOWEVER, THERE ARE NO TEST/COLLECTION TIMES OR DATES ASSOCIATED WITH THE COMPLAINT. 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. THE INVESTIGATION IS UNDERWAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16768237 ↗MalfunctionApr 11, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ON (B)(6)2023, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGE THAT YIELDED A DISCREPANT POTASSIUM RESULT OF >9.0 ON A PATIENT. THERE WAS NO PATIENT INFORMATION AT THE TIME OF THIS REPORT. METHOD, DATE, NA, K. I-STAT (B)(6)2023 134 >9.0. LAB (B)(6)2023 140 4.9. INFORMATION REQUESTED BUT TO NO AVAIL: TEST/COLLECTION TIMES, PRODUCT/LOT# INFORMATION, EVENT DETAILS. 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. THE INVESTIGATION IS UNDERWAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16716610 ↗MalfunctionMar 30, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ON (B)(6) 2023, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGE THAT YIELDED DISCREPANT POTASSIUM RESULTS ON A PATIENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. METHOD, DATE TESTED, RESULT, SAMPLE, CARTRIDGE, LOT#: I-STAT (B)(6) 2023 10:46 2.0 MEQ/L B CHEM8+ H22316; VS2 (B)(6) 2023 02:15 2.6 MMOL/L B CHEM8+ H22316; I-STAT (B)(6) 2023 20:39 3.0 MEQ/L C CG8+ W22291;VS2 (B)(6) 2023 21:21 4.6 MMOL/L C CG8+ W22291; I-STAT (B)(6) 2023 02:51 3.1 MEQ/L A CHEM8+ H22316; VS2 (B)(6) 2023 03:39 4.2 MMOL/L A CHEM8+ H22316. 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. THE INVESTIGATION IS UNDERWAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16646249 ↗MalfunctionFeb 8, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
MalfunctionSep 14, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ON (B)(6) 2022, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT RESULTS ON A PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. I-STAT 7.5 A, CRRT FILTERED 4.1 NI, I-STAT 4.1 B. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15417608 ↗MalfunctionApr 14, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ON 05-APR-2022, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT CREATININE RESULTS ON A 80 YEAR OLD MALE PATIENT WITH ABDOMINAL PAIN. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. (B)(6). THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY.
Patient problems: Abdominal Pain
MAUDE report 14111802 ↗MalfunctionMar 20, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ON (B)(6) 2022, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT RESULTS ON A 50 YEAR OLD FEMALE PATIENT. THE DISCREPANT RESULTS OCCURED AT 15:03 WITH SAMPLE A. PATIENT WAS SUSPECTED TO HAVE LOW HEMOGLOBIN. THE HEMOGLOBIN RESULTS VARIED. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. (B)(6). THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. IT IS SUSPECTED THAT THE RESULTS FOR 15:03, SAMPLE A WAS A HEMOLYZED SAMPLE. HOWEVER, THIS COULD NOT BE CONFIRMED AT THE TIME OF THIS REPORT. THE INVESTIGATION IS UNDERWAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13828292 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K053110. One submission often covers many models, so check the product and lot details in each record.
- Z-1846-2025 · Apr 24, 2025 · Open, ClassifiedABBOTT POINT OF CARE TEST CREA I-STAT (25/BX) ABBTPT CARTRIDGE.
- Z-2022-2011 · Feb 15, 2011 · Terminatedi-STAT CHEM 8+ Cartridge, List Number 03P91-25; 510 K053110 Useful for monitoring a variety of conditions. The panel of tests is used in the hospital environment to assess kidney
- Z-1791-2010 · Feb 5, 2010 · Terminatedi-STAT CHEM8+ cartridges The i-stat Hematocrit (Hct) is intended for use in the in vitro quantification of packed red blood cell volume in arterial, venous, or capillary whole blo
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- i-STAT 03P81-25Abbott Point Of Care Inc. · ELECTRODE, ION SPECIFIC, SODIUM15 reports
- i-STAT 03P82-25Abbott Point Of Care Inc. · ELECTRODE, ION SPECIFIC, SODIUM10 reports
- i-STAT 03P80-25Abbott Point Of Care Inc. · ELECTRODE, ION SPECIFIC, SODIUM9 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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