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Terminated

Immunoassay Premium Plus Controls (3x4x5mL and 12x5mL packages)

FDA Recall Z-0970-2018 · Posted None

Recalling FirmRandox Laboratories
Recall StatusTerminated
Product CodeJJY
Date Initiated2017-08-11
Date Terminated2019-03-29
Product Quantity199 Kits

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.

Firm Action

On July 24, 2017 an Urgent notice was issued instructing customers to place a copy a notice in all kits remaining in stock. This notifies customers that they should amend the claims for open stability in the instructions for use, to state use immediately after the 30 minute reconstitution period. Questions or concerns can be emailed to [email protected]

Root Cause

Device Design

Distribution Pattern

Distribution US nationwide.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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