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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87501

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
November 23, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Diasorin Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

LIAISON 1-84 PTH Assay - Product Usage: is 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.

Z-1342-2021
Recall number
Z-1342-2021
Initiated
November 23, 2020
Classification
Class II
Status
Terminated
Recalling firm
Diasorin Inc.
Quantity
5,895 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for system to produce falsely elevated parathyroid hormone (PTH) results from patient samples.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

REF 310630; lot numbers: 134909, 134909A and 134909B; UDI: 08056771600125

Distribution pattern

Worldwide distribution - US Nationwide in the states of KY, OH, GA, PA, FL and the countries of Canada, Argentina, Bahrain, Bosnia & Herzegovnia, Iraq, Jordan, Morocco, Nepal, Russia, Serbia, Singapore, Taiwan, Thailand, Tunisia, Dubai, Italy, Israel, Brazil, Mexico, Australia, and Bulgaria.