Exact FDA event identifier

Event 86238

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: July 30, 2020
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

2 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 2

AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma

Z-2965-2020

Recall number: Z-2965-2020
Initiated: July 30, 2020
Classification: Class II
Status: Terminated
Recalling firm: RANDOX LABORATORIES, LTD.
Quantity: 143 kits in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Randox Ammonia reagents are being recalled from the field due to a positive bias of up to 140¿mol/l being observed on 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

Randox Ammonia reagents are being recalled from the field due to a positive bias of up to 140¿mol/l being observed on patient samples.

Code information

Catalogue Number: AM1015 GTIN: 05022273200256 Lot #: 517541 batch 517541

Distribution pattern

US Distribution to states of: VA, UT, WV and country of : Canada

device · product 2 of 2

AM1054 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma

Z-2966-2020

Recall number: Z-2966-2020
Initiated: July 30, 2020
Classification: Class II
Status: Terminated
Recalling firm: RANDOX LABORATORIES, LTD.
Quantity: 143 kits in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Randox Ammonia reagents are being recalled from the field due to a positive bias of up to 140¿mol/l being observed on 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

Randox Ammonia reagents are being recalled from the field due to a positive bias of up to 140¿mol/l being observed on patient samples.

Code information

Catalogue Number: AM1054 GTIN: 05055273200263 Lot #: 512103 batch 512103

Distribution pattern

US Distribution to states of: VA, UT, WV and country of : Canada