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Terminated

Randox Rx Series Mg - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG8326

FDA Recall Z-0547-2021 · Posted None

Recalling FirmRandox Laboratories Ltd.
Recall StatusTerminated
Product CodeJGJ
Date Initiated2020-11-13
Date Terminated2021-04-01
Product Quantity4 kits

Reason for Recall

Failing to meet the linearity performance claims quoted on the kit inserts-The linearity is reduced by approximately -30% for Serum/ Plasma and -50% for Urine

Firm Action

Randox issued Urgent Medical Device Correction letter via e-mail to US Customers on 13 November 2020 stating reason for recall, health risk and action to take: Discontinue use of and discard any of the above immediately. " Review your reagent inventory of these products and assess your laboratories needs for reimbursement for discarded inventory. " Review results generated with the affected batches in line with the clinical profile of the patient. " Discuss the contents of this notice with your Medical Director. " Complete and return the response form 12187-QA to technical. [email protected] within five working days. Questions or concerns, please contact Randox Technical Services.

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide distribution in the states of GA, NJ.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K162200Randox RX Daytona Plus Magnesium (MG)Randox Laboratories, Ltd. · 2017-04-28

Official Source

View FDA Recall →

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

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