Z-0904-2023 Class II Ongoing
FDA device recall Z-0904-2023 was initiated by Randox Laboratories Ltd. on Nov 22, 2022 and is designated Class II. 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 The recall status is ongoing. Affected quantity: 115 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 11, 2023
- Initiation Date
- Nov 22, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 115 units
Product 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
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: 05055273204902 Lot Number/Exp. Date: 585LPC 28thJun 23; 601LPC 28th Nov 23; 612LPC 28th Sep 24
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0904-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026