CLASS II ONGOING Device recall · Reported 15 May 2024 · FDA Enforcement Report

Clinical Chemistry Calibration Serum recalled by Randox Laboratories

Randox Laboratories is recalling Clinical Chemistry Calibration Serum (, distributed nationwide in the US. The recall was initiated on 5 Mar 2024 and the FDA has classified it as Class II.

Check your package

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

Quantity recalled80,366 units (US: 242 units; OUS: 80,094 units)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1759-2024
FDA event ID: 94358
Recalling firm: Randox Laboratories, Crumlin (North), N/A
Classification: Class II
Status: Ongoing
Recall initiated: 5 Mar 2024
FDA classified: 3 May 2024
Reported: 15 May 2024
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

5 Mar 2024	Recall initiated by company
3 May 2024	Classified by FDA	+59 days
15 May 2024	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

Domestic: Nationwide Distribution.

Nationwide

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

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

Where was it sold?

Domestic: Nationwide Distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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