Liquid Assayed Specific Protein- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immu
FDA device recall Z-0903-2023 · posted 2023-01-05 · Open, Classified
Recall details
- Recalling firm
- Randox Laboratories Ltd.
- 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
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- JJY
- Quantity affected
- 146 units US
- Distribution
- US Nationwide distribution in the states of CA, FL, OH,ME, MO, NC, NJ, PA, TN.
- Date initiated
- 2022-11-22
- Date posted
- 2023-01-05
- Location
- Crumlin, North, Ireland
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RANDOX ASSAYED SPECIFIC PROTEIN CONTROL (K972608) | Randox Laboratories, Ltd. | 1997-08-04 |