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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94358

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

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Event summary

Timeline bucket
March 05, 2024
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

Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clinical chemistry tests.

Z-1759-2024
Recall number
Z-1759-2024
Initiated
March 05, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Randox Laboratories Ltd.
Quantity
80,366 units (US: 242 units; OUS: 80,094 units)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Randox Laboratories has identified that Inorganic Phosphate in Calibration Serum Level 3, CAL2351 & CAL10388, is running with a negative bias on RX Series instruments compared to other methods.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Randox Laboratories has identified that Inorganic Phosphate in Calibration Serum Level 3, CAL2351 & CAL10388, is running with a negative bias on RX Series instruments compared to other methods.

Code information

Catalogue No. CAL2351 & CAL10388; GTIN: 05055273200966; Lot No. 1260UE, 1262UE, 1295UE, 1297UE, 1298UE, 1315UE, 1325UE, 1326UE, 1295UE, & 1325UE.

Distribution pattern

Domestic: Nationwide Distribution.