Immunoassay Premium Controls (3x4x5mL and 12x5mL packages)

The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconstituted stability claim in the product IFU.

Recall #: Z-0969-2018
Affected scope: 117 Kits
Initiated: August 11, 2017

Compiled from official public sources by the publisher. · Updated September 2026

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Randox Laboratories recalled Immunoassay Premium Controls (3x4x5mL and 12x5mL packages) - a low-severity action.

Immunoassay Premium Controls (3x4x5mL and 12x5mL packages) was recalled by Randox Laboratories in March 21, 2018. Reason: The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconstituted stabi…. Check the official notice for the remedy. Verify recall #Z-0969-2018 with the FDA Devices before acting.

The recall

Randox Laboratories issued this low-severity FDA Devices recall-The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconstituted stabi….

Low
severity level: Class III
classification: March 21, 2018
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0969-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified low severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

Immunoassay Premium Controls (3x4x5mL and 12x5mL packages)

Reason for recall

The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconstituted stability claim in the product IFU.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Low (Class III)
Status	Terminated
Recall number	Z-0969-2018
Date reported	March 21, 2018
Date initiated	August 11, 2017
Recalling firm	Randox Laboratories
Firm location	Kearneysville, WV
Affected scope	117 Kits
Distribution	Distribution US nationwide.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-0969-2018) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Immunoassay Premium Controls (3x4x5mL and 12x5mL packages). Recalled by Randox Laboratories. Units affected: 117 Kits.

Why was this product recalled? ▼

The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconstituted stability claim in the product IFU.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on March 21, 2018. Severity: Low. Recall number: Z-0969-2018.

Where was the recalled product distributed? ▼

Distribution: Distribution US nationwide..

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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This recall: FDA Devices, reported March 21, 2018. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026