Randox Mg R1 - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG3880
Reported: December 16, 2020 Initiated: November 13, 2020 #Z-0546-2021
Product Description
Randox Mg R1 - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG3880
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
Details
- Recalling Firm
- Randox Laboratories Ltd.
- Units Affected
- 1 kit
- Distribution
- US Nationwide distribution in the states of GA, NJ.
- Location
- Crumlin (North), N/A
Frequently Asked Questions
What product was recalled? ▼
Randox Mg R1 - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG3880. Recalled by Randox Laboratories Ltd.. Units affected: 1 kit.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 16, 2020. Severity: Moderate. Recall number: Z-0546-2021.
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