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Randox Laboratories Ltd. Recall 91225

Description: Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2683

Randox Laboratories Ltd. Recall 91225 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0904-2023
Event ID91225
Event DescriptionLiquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2683
Product TypeDevices
DistributionUS Nationwide distribution in the states of CA, FL, OH,ME, MO, NC, NJ, PA, TN.
Quantity115 units
Recall ReasonConcentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range
Device Classification20230111
Device Code InfoGTIN: 05055273204902 Lot Number/Exp. Date: 585LPC 28thJun 23; 601LPC 28th Nov 23; 612LPC 28th Sep 24
Center Classification Date20230105
Recall Initiation Date20221122
Recalling FirmRandox Laboratories Ltd.
Initial Notification E-Mail
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