Z-0905-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- January 11, 2023
- Initiation Date
- November 22, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 49 units US
Product Description
Liquid Assayed Specific Protein Control Level 3- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2684
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 Pattern
US Nationwide distribution in the states of CA, FL, OH,ME, MO, NC, NJ, PA, TN.
Code Information
GTIN: 05055273204919 Lot Number/Exp. Date: 586LPC 28th Jun 23; 602LPC 28th Nov 23; 628LPC 28th Dec 24;