Liquid Assayed Specific Protein- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2682 Control Level 1
- Recall Initiated
- November 22, 2022
- Posted
- January 5, 2023
- Recall Number
- Z-0903-2023
- Quantity
- 146 units US
Reason for Recall
Concentration 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
Distribution
US Nationwide distribution in the states of CA, FL, OH,ME, MO, NC, NJ, PA, TN.
Lot / Code Info
GTIN: 05055273204896 Lot Number/Exp. Date: 584LPC 28th Jun 23; 600LPC 28th Nov 23; 611LPC 28th Sep 24;
Root Cause
Under Investigation by firm
Action Taken
Randox Laboratories Ltd issued via email to the US Distributor Randox Laboratories-US, Ltd., Kearneysville, West Virginia on 11/22/22. The US Distributor contacted the customers by letter on 11/28/22. The Urgent Medical Device Correction letter states reason for recall, health risk and action to take: Discard previous IFUs and download the updated IFUs from randox.com 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.services@randox.com within five working days. Transmission of Field Safety Notice: Send a copy of the FSN to all affected customers and to those who need to be aware within your organization.