Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and rep
FDA device recall Z-2021-2023 · posted 2023-06-28 · Open, Classified
Recall details
- Recalling firm
- Randox Laboratories Ltd.
- Reason for recall
- Delay in reporting results due to Quality Controls running high outside of range. Target value and range for ACTH in Immunoassay Premium Level 3, IA2640, lot 2031EC and Immunoassay Premium Control Tri Level kit batch 583135 lot 2031EC has been reassigned on the Roche Cobas e801 due to High recovery outside range
- Action taken
- Randox issued via email to the Distributor Medical Device Correction Letter and forwarded to US and PR customers on 04 May, 2023. Letter states reason for recall, health risk and action to take: Discontinue use of and discard the current IFU and download the updated IFU from randox.com Discuss the contents of this notice with your Medical Director. Complete and return the response for 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. If you have any questions or concerns please contact Randox Technical Services.
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- JJY
- Quantity affected
- 1 kit
- Distribution
- CA, IL, VA, WA, WI including PR
- Date initiated
- 2023-05-04
- Date posted
- 2023-06-28
- Location
- Crumlin, North, Ireland
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY PREMIUM PLUS TRI-LEVEL CONTROL (K140522) | Randox Laboratories Limited | 2014-05-22 |