Lactate Dehydrogenase acc. to IFCC ver.2 5401674190Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04015630926961), received between Apr 14, 2023 and Feb 21, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “High Test Results” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K964457); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 21, 2025Incorrect Measurement; High Test Results; Incorrect Measurement; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2 (ALP) AND LACTATE DEHYDROGENASE (LDH) RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL ALP RESULT WAS 213 U/L. THE REPEATED RESULTS WERE 148 U/L, 64.8 U/L, 64.6 U/L, AND 170 U/L. THE INITIAL LDH RESULT WAS 419 U/L AND THE REPEATED RESULTS WERE 277 U/L AND 259 U/L. THE LEUKOCYTE VALUES IN THIS SAMPLE WERE IN THE NORMAL RANGE. THIS MEDWATCH WILL APPLY TO THE LACTATE DEHYDROGENASE ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER: (B)(6) FOR INFORMATION RELATED TO THE ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2 ASSAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21433608 ↗
• MalfunctionApr 14, 2023High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE LDHI2 LACTATE DEHYDROGENASE ACC. TO IFCC VER.2 RESULTS FROM TWO PATIENT SAMPLES TESTED ON THE COBAS C 111 W/O ISE WITH SERIAL NUMBER (B)(4). THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE INITIAL RESULTS WERE CONSIDERED HIGH WHICH PROMPTED THE RERUN OF THE PATIENT SAMPLES. SAMPLE 1: ON (B)(6) 2023, THE INITIAL RESULT WAS 663.9 U/L. THE FIRST REPEAT RESULT WAS 214.8 U/L. THE SECOND REPEAT RESULT WAS 223.3 U/L. SAMPLE 2: ON (B)(6) 2023, THE INITIAL RESULT WAS 360.1 U/L. THE FIRST REPEAT RESULT WAS 259.9 U/L. THE SECOND REPEAT RESULT WAS 273.2 U/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16742572 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K964457. One submission often covers many models, so check the product and lot details in each record.

• Z-1146-2019 · Dec 17, 2018 · Terminated
  Lactate Gen.2, Catalog Nos. 03183700190, 05171881190, 11822837190, ***added as of 5/10/19*** 03183700190 Product Usage: An In vitro diagnostic reagent system intended for use on
• Z-1926-2015 · May 7, 2015 · Terminated
  Lactate. Intended for use on COBAS INTEGRA 800 and 400 plus systems, cobas c111, Roche/Hitachi MODULAR systems, and cobas c systems for the quantitative determination of lactate c