Recall Z-2022-2023
Randox Laboratories Ltd. · initiated May 4, 2023
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes Catalog Number: IA2633
Codes / lots: GTIN: 05055273203837 Batch/Lot Number: 583135 Exp. Date: 28th April 23
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
FDA-determined cause: Nonconforming Material/Component
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.
Details
- Recall number
- Z-2022-2023
- Initiated
- May 4, 2023
- Posted by FDA
- June 28, 2023
- Product code
- JJY – Multi-Analyte Controls, All Kinds (Assayed)
- Quantity
- 30 kits
- Distribution
- CA, IL, VA, WA, WI including PR
- Recalling firm
- Randox Laboratories Ltd., Crumlin, North
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2021-2023 Class III | Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material…Delay in reporting results due to Quality Controls running high outside of range. Target value and range for… | 05/04/2023Open, Classified |