Device product
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
Z-0903-2023
Product summary
- Event
- Event 91225
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 146 units US
- Official record key
device-enforcement:Z-0903-2023
Official wording
Reason: 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
Code information: GTIN: 05055273204896 Lot Number/Exp. Date: 584LPC 28th Jun 23; 600LPC 28th Nov 23; 611LPC 28th Sep 24;
Distribution pattern: US Nationwide distribution in the states of CA, FL, OH,ME, MO, NC, NJ, PA, TN.
Derived failure modes
-
Unknown
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