The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Devices)·Z-2021-2023·Announced 2023-07-05

FDA Recalls Immunoassay Quality Control Material for Out-of-Range Values

Randox Laboratories has recalled a quality control product used in laboratory testing because control values are running outside their target ranges. This can delay when test results are reported.

The agency’s classification

FDA (Devices): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class III recall with no reported illnesses or injuries. The out-of-range quality control values caused delays in laboratory result reporting. Class III recalls are typically scored 1 or 2; Moderate is assigned because the issue affects laboratory operations and diagnostic accuracy monitoring.

Plain-English summary

Randox Laboratories Ltd. has recalled Immunoassay Premium Level 3, a quality control material used in clinical laboratories to verify the accuracy and consistency of test results. The product (Catalog IA2640, lot 2031EC, expiring November 28, 2023) is used on Roche Cobas e801 automated analyzers to monitor ACTH (adrenocorticotropic hormone) test performance.

The recall was initiated because quality control values in the affected lot are running outside the manufacturer's target range and acceptable limits. Out-of-range quality control results can delay the completion and reporting of patient test results and may compromise the ability to verify test accuracy.

The recalled product was distributed to clinical laboratories in California, Illinois, Virginia, Washington, Wisconsin, and Puerto Rico. Randox Laboratories has reassigned the target values and acceptable ranges for ACTH in the affected lot and in the related Immunoassay Premium Control Tri Level kit (batch 583135, lot 2031EC).

The recalled product

Product
Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes. Catalog Number: IA2640
Manufacturer
Randox Laboratories Ltd.
Category
Medical Device — In Vitro Diagnostic QC Material
Hazard
Affected units
1

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

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

Distribution

Distributed in 6 states:

Part of a larger recall action

This product is one of 2 recalled by Randox Laboratories Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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