i-STAT 02R60-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00054749002597), received between Mar 16, 2022 and Jun 20, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON 02-MAY-2023, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT ALINITY ANALYZER SN (B)(6) THAT YIELDED A DISCREPANT RESULT OF >1000 ON A PATIENT. THERE WAS NO PATIENT INFORMATION, EVENT DETAILS, NOR ADDITIONAL TEST AVAILABLE AT THE TIME OF THE INITIAL CALL. ON (B)(6) 2023 THE CUSTOMER PROVIDED RESULTS BUT NO PATIENT INFORMATION OR DETAILS SURROUNDING THE EVENT. THE CUSTOMER IS RETURNING THE I-STAT ALINITY SN (B)(6) FOR INVESTIGATION. METHOD DATE TESTED RESULTS HEPARIN HEPARIN DOSE SN(B)(6) 26-APRIL-2023 10:59 596 10:54 400IE/KG + 10000IE PRIMING) SN(B)(6) 26-APRIL-2023 10:59 693 10:44 400IE/KG + 10000IE PRIMING) SN(B)(6) 26-APRIL-2023 11:33 521 11:44 5000 IE SN(B)(6) 26-APRIL-2023 11:33 567 11:44 5000 IE SN(B)(6) 26-APRIL-2023 12:21 636 NI NI SN(B)(6) 26-APRIL-2023 12:21 734 NI NI SN(B)(6) 26-APRIL-2023 13:08 492 NI NI SN(B)(6) 26-APRIL-2023 13:08 601 NI NI SN(B)(6) 26-APRIL-2023 13:36 400 NI NI SN(B)(6) 26-APRIL-2023 13:36 486 NI NI SN(B)(6) 26-APRIL-2023 14:58 >1000 14:17 NI SN(B)(6) 26-APRIL-2023 14:58 325 14:17 NI PER I-STAT SYSTEM MANUAL (ART: 714185-00Q), THE I-STAT KAOLIN ACTIVATED CLOTTING TIME (KAOLINACT) TEST IS AN IN VITRO DIAGNOSTIC TEST THAT USES FRE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17161974 ↗
• MalfunctionMar 16, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  ON (B)(6) 2022, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER WHO REPORTED THAT I-STAT ANALYZER SN (B)(4) WAS EXTREMELY HOT BEFORE THEY POWERED IT OFF THE EVENING BEFORE THE ERROR CODE 0500.0001.0001.0003.0001 APPEARED DURING OPERATION. THERE WAS NO ADDITIONAL INFORMATION AT THE TIME OF THIS REPORT. THERE WERE NO INJURIES REPORTED. THE ANALYZER WAS REPLACED AT NO CHARGE AND RETURNING FOR INVESTIGATION. THE PRODUCT WAS REPLACED AND RETURNING FOR INVESTIGATION. BASED ON THE INFORMATION AVAILABLE, THERE WERE NO PATIENT OR USER RELATED INJURIES ASSOCIATED WITH THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13789990 ↗