Recall Z-0904-2023
Randox Laboratories Ltd. · initiated November 22, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: GTIN: 05055273204902 Lot Number/Exp. Date: 585LPC 28thJun 23; 601LPC 28th Nov 23; 612LPC 28th Sep 24
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
FDA-determined cause: Under Investigation by firm
Action taken
Randox Laboratories Ltd issued via email to the US Distributor Randox Laboratories-US, Ltd., Kearneysville, West Virginia on 11/22/22. The US Distributor contacted the customers by letter on 11/28/22. The Urgent Medical Device Correction letter states reason for recall, health risk and action to take: Discard previous IFUs and download the updated IFUs from randox.com Review results generated with the affected batches in line with the clinical profile of the patient. Discuss the contents of this notice with your Medical Director. Complete and return the response form 12187-QA to technical.services@randox.com within five working days. Transmission of Field Safety Notice: Send a copy of the FSN to all affected customers and to those who need to be aware within your organization.
Details
- Recall number
- Z-0904-2023
- Initiated
- November 22, 2022
- Posted by FDA
- January 5, 2023
- Product code
- JJY – Multi-Analyte Controls, All Kinds (Assayed)
- Quantity
- 115 units
- Distribution
- US Nationwide distribution in the states of CA, FL, OH,ME, MO, NC, NJ, PA, TN.
- Recalling firm
- Randox Laboratories Ltd., Crumlin, North
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0903-2023 Class II | Liquid Assayed Specific Protein- In vitro diagnostic use, in the quality control of…Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in… | 11/22/2022Open, Classified |
| Z-0905-2023 Class II | Liquid Assayed Specific Protein Control Level 3- In vitro diagnostic use, in the quality…Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in… | 11/22/2022Open, Classified |