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
Recall
- Recall Number
- Z-0904-2023
- Event Number
- 91225
- Firm
- Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland
- FEI Number
- 1000361607
- Product Code
- JJY
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- November 22, 2022
- Posted
- January 5, 2023
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
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
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 [email protected] 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.
US Nationwide distribution in the states of CA, FL, OH,ME, MO, NC, NJ, PA, TN.
115 units