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
Reported: January 11, 2023 Initiated: November 22, 2022 #Z-0903-2023
Product Description
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
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
Details
- Recalling Firm
- Randox Laboratories Ltd.
- Units Affected
- 146 units US
- Distribution
- US Nationwide distribution in the states of CA, FL, OH,ME, MO, NC, NJ, PA, TN.
- Location
- Crumlin (North), N/A
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Randox Laboratories Ltd.. Units affected: 146 units US.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 11, 2023. Severity: Moderate. Recall number: Z-0903-2023.
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