Randox Laboratories Ltd. Recall 91225
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
Randox Laboratories Ltd. Recall 91225 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0904-2023 |
| Event ID | 91225 |
| Event 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 |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of CA, FL, OH,ME, MO, NC, NJ, PA, TN. |
| Quantity | 115 units |
| Recall 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 |
| Device Classification | 20230111 |
| Device Code Info | GTIN: 05055273204902 Lot Number/Exp. Date: 585LPC 28thJun 23; 601LPC 28th Nov 23; 612LPC 28th Sep 24 |
| Center Classification Date | 20230105 |
| Recall Initiation Date | 20221122 |
| Recalling Firm | Randox Laboratories Ltd. |
| Initial Notification | |
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