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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93775

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

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Event summary

Timeline bucket
November 29, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
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

RX Series Copper (Cu) Assay Ref. Number CU2340

Z-0992-2024
Recall number
Z-0992-2024
Initiated
November 29, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Randox Laboratories Ltd.
Quantity
3,053 kits (2 US, 3,051 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Randox Laboratories have released an update to the Carryover Avoidance Technical Bulletin to detail that Copper, should not be run directly after Total Protein, on the RX series instruments testing order. If copper assay is run after total protein it could lead to falsely elevated copper results.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Randox Laboratories have released an update to the Carryover Avoidance Technical Bulletin to detail that Copper, should not be run directly after Total Protein, on the RX series instruments testing order. If copper assay is run after total protein it could lead to falsely elevated copper results.

Code information

Catalogue Number/GTIN: CU2340 05055273201949; Lot/batch: 592278, 610661, 610669, 629021, 647201, 657944;

Distribution pattern

US Nationwide distribution in the states of SC and OK.