Atellica CH Trig 11097591Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00630414596495), received between Nov 7, 2021 and Nov 7, 2021 — classified as 1 malfunction.

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

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K133067); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jan 27, 2023Class IIOpen, Classified

   Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results

   Z-1270-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

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

• MalfunctionNov 7, 2021Low Test Results; Low Test Results

  AN ATELLICA CH 930 INSTRUMENT GENERATED A LIPEMIC INDEX VALUE OF 0 ON A PATIENT SAMPLE. THE SAMPLE WAS VISUALLY INSPECTED BY THE OPERATOR AND WAS RATED AS HAVING A LIPEMIC INDEX OF 4. THE SAME SAMPLE WAS REPORTEDLY TESTED FOR TRIGLYCERIDE, SODIUM AND POTASSIUM. THE SAMPLE WAS REPEAT TESTED FOR SODIUM AND POTASSIUM USING AN ALTERNATE INSTRUMENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE LIPEMIC INDEX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12763124 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K133067. One submission often covers many models, so check the product and lot details in each record.

• Z-1657-2016 · Mar 17, 2016 · Terminated
  ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT & ADVIA CHEMISTRY TRIGLYCERIDES_2 Concentrated (TRIG_c) REAGENT
• Z-1670-2016 · Mar 7, 2016 · Terminated
  ADVIA Chemistry Triglyceride_2, concentrated; TRIG_c; Catalog # SMN # 10697575. For in vitro diagnostic use in the quantitative measurement of triglycerides in human serum and pla