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Lactate Dehydrogenase acc to IFCC ver2 5169330190Recalls & reported problems

Roche Diagnostics GmbH · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04015630925056), received between Jan 28, 2019 and Jan 28, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Low Test Results” (1 report).

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

Device problems

  • Low Test Results1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 28, 2019Low Test Results; Low Test Results

    THIS REPORT SUMMARIZES <NOE>1</NOE> MALFUNCTION EVENT. AN ERRONEOUS LOW RESULT WAS GENERATED BY THE COBAS 8000 C 702 MODULE. THE EVENT INVOLVED 1 PATIENT WITH AN ERRONEOUS RESULT FOR LDHI2 LACTATE DEHYDROGENASE ACC. TO IFCC VER.2. THE PATIENT'S AGE WAS REQUESTED BUT WAS NOT PROVIDED. THE PATIENT'S WEIGHT WAS REQUESTED BUT WAS NOT PROVIDED. THE PATIENT'S GENDER WAS REQUESTED BUT WAS NOT PROVIDED. THE PATIENT'S RACE WAS REQUESTED BUT WAS NOT PROVIDED. THE PATIENT'S ETHNICITY WAS REQUESTED BUT WAS NOT PROVIDED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8281628 ↗

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

Other NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE devices

All NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.