Device product
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
Z-0904-2023
Product summary
- Event
- Event 91225
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 115 units
- Official record key
device-enforcement:Z-0904-2023
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: 05055273204902 Lot Number/Exp. Date: 585LPC 28thJun 23; 601LPC 28th Nov 23; 612LPC 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