Based on an unusual rate of complaints from the field for "Substrate error" leading to a potential delayed results on different References tested on all Systems, Biomerieux initiated an investigation. The substrate error issue was confirmed on all lots of Immuno-Assays manufactured with substrate batches using the common lot of raw material (4-MUP). The only potential risk associated with the substrate error is a delayed result as you need to run another test. There is no risk of false results. The investigation demonstrates that the issue occurs over the product shelf-life. The analyzes of the kinetic model allowed to define a revised expiry date for each impacted lot of Immuno-Assays finished products. When used until the revised expiry date, the product continues to perform per its registered performance specifications. Therefore, corrective actions involving a revised expiration date for all lots of clinical Immunoassay products are required to ensure that the specified products will continue to perform per their labelled performance specifications. Recall date: 2021-10-19
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