Exact FDA event identifier

Event 79767

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

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Event summary

Timeline bucket: March 02, 2018
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Randox Laboratories Ltd.

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

Lipase, Catalog number: LI3837; GTIN: 05055273204230 and Catalog number: LI8361; GTIN: 05055273214284 Product Usage: For Professional Use for the quantitative in vitro determination of Lipase in human serum and plasma. Lipase measurements are used in the diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct.

Z-1631-2018

Recall number: Z-1631-2018
Initiated: March 02, 2018
Classification: Class II
Status: Terminated
Recalling firm: Randox Laboratories Ltd.
Quantity: 8

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Randox has now released further steps to avoid contamination of the Lipase Assay on Rx instruments.

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.

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Inspect official wording and provenance

Reason for recall

Randox has now released further steps to avoid contamination of the Lipase Assay on Rx instruments.

Code information

Lot numbers: 428000, 404175, and 404245

Distribution pattern

US Nationwide Distribution in the states of West Virginia and Puerto Rico