Reported Apr 7, 2021 · Terminated

LIAISON 1-84 PTH Assay - Product Usage: is an in vitro chemiluminescent immunoassay (CLIA) intended for the…

Diasorin Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Diasorin Inc. · 1951 Northwestern Ave S · Stillwater, MN · 55082-7536

Is this the product you have?

  • LIAISON 1-84 PTH Assay - Product Usageis an in vitro chemiluminescent immunoassay (CLIA) intended for the quantitative determination of parathyroid hormone (1-84) in human serum and EDTA plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia and hypocalcemia resulting from disorders of calcium metabolism. The test has to be performed on the LIAISON¿ Analyzer family
Lot codes and dates
  • REF 310630
  • lot numbers
    • 134909
    • 134909A and 134909B
  • UDI08056771600125
Amount recalled
5,895 devices

Where it was sold

Why it was recalled

Potential for system to produce falsely elevated parathyroid hormone (PTH) results from patient samples.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 6, 2023 · Data as of Sep 19, 6:26 PM UTC

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