Intact-PTH [Parathyroid Hormone] ELISA [Enzyme-Linked ImmunoSorbent Assay] 7022Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08305900070224), received between Dec 5, 2016 and Dec 5, 2016 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Output Problem” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K974306); 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.

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.

• MalfunctionDec 5, 2016Output Problem; Output Problem

  THE POTENTIAL ISSUE IS ASSOCIATED WITH HIGH BACKGROUND BEING OBSERVED FOR CALIBRATOR A. ELEVATED OPTICAL DENSITY (OD 450 NM) OF CALIBRATOR A MAY CAUSE LOSS OF SEPARATION BETWEEN CALIBRATORS A AND B, WHICH MAY IMPACT THE ASSAY CALIBRATION. LOSS OF SEPARATION WAS OBSERVED FROM KIT LOT 2494, 2494B.

  Patient problems: No Patient Involvement

  MAUDE report 6145532 ↗
• MalfunctionDec 5, 2016Output Problem; Output Problem

  THE POTENTIAL ISSUE IS ASSOCIATED WITH HIGH BACKGROUND BEING OBSERVED FOR CALIBRATOR A. ELEVATED OPTICAL DENSITY (OD 450 NM) OF CALIBRATOR A MAY CAUSE LOSS OF SEPARATION BETWEEN CALIBRATORS A AND B, WHICH MAY IMPACT THE ASSAY CALIBRATION. LOSS OF SEPARATION HAS BEEN REPORTED FROM KIT LOT NUMBER 2488.

  Patient problems: No Patient Involvement

  MAUDE report 6145519 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K974306. One submission often covers many models, so check the product and lot details in each record.

• Z-1520-2018 · Oct 26, 2016 · Terminated
  Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification of Intact Parathyroid Hormone (PTH) in serum.