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Randox Laboratories Ltd. Recall 88999

Description: RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200

Randox Laboratories Ltd. Recall 88999 Information

StatusTerminated
Mandated?Voluntary: Firm initiated
Recall NumberZ-0328-2022
Event ID88999
Event DescriptionRANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200
Product TypeDevices
DistributionUS Nationwide distribution in the states of GA, OR, PA ,WA, West Virginia.
Quantity15 kits
Recall ReasonWhen calibrating using the standard provided in the kit, the change in absorbance is lower than expected generating internal quality control results high outside range
Device Classification20211208
Device Code InfoLot Numbers/Exp Date: 559344 28th June 2022; 572730 28th July 2023. GTIN: 05055273201130
Center Classification Date20211201
Recall Initiation Date20211101
Recalling FirmRandox Laboratories Ltd.
Initial Notification E-Mail
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