CLASS III ONGOING Device recall · Reported 5 Jul 2023 · FDA Enforcement Report

Immunoassay Premium Level vitro diagnostic use recalled

Randox Laboratories is recalling Immunoassay Premium Level vitro diagnostic use, as assayed quality control material to, distributed in California, Illinois, Puerto Rico, Virginia, Washington, Wisconsin. The recall was initiated on 4 May 2023 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesGTIN:05055273203868 Batch/Lot Number: 2031EC Exp. Date: 28th Nov 23

Quantity recalled1 kit

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-2021-2023
FDA event ID: 92344
Recalling firm: Randox Laboratories, Crumlin (North), N/A
Classification: Class III
Status: Ongoing
Recall initiated: 4 May 2023
FDA classified: 28 Jun 2023
Reported: 5 Jul 2023
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Potency & Assay
Device type: Patient Monitors

Timeline

4 May 2023	Recall initiated by company
28 Jun 2023	Classified by FDA	+55 days
5 Jul 2023	Published in enforcement report	+7 days

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

Reason for recall

Delay in reporting results due to Quality Controls running high outside of range. Target value and range for ACTH in Immunoassay Premium Level 3, IA2640, lot 2031EC and Immunoassay Premium Control Tri Level kit batch 583135 lot 2031EC has been reassigned on the Roche Cobas e801 due to High recovery outside range

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes. Catalog Number: IA2640

Where it was distributed

CA, IL, VA, WA, WI including PR

California Illinois Puerto Rico Virginia Washington Wisconsin

Stores named: Target

Questions about this recall

Why was it recalled?

Which lots are affected?

GTIN:05055273203868 Batch/Lot Number: 2031EC Exp. Date: 28th Nov 23

Where was it sold?

CA, IL, VA, WA, WI including PR

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 III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

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.

Other products in this recall event

1 other product · FDA event 92344

Reported	Class	Recall	Company	Reason	Where
5 Jul 2023	CLASS III	Immunoassay Premium Control Tri Level-In vitro diagnostic recalled	Randox Laboratories	Potency & Assay	6 states

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