Phadia Ab Rapsgatan Plant Rapsgatan 7 Uppsala Sweden Phadia" 1000 Model # 12-3800-01 Product Usage: The instrument is fully integrated and automated instrument including software for immunodiagnostic testing. The instrument is designed to handle all steps from sample and reagent handling to processing of results. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

code 7-102 Liquid Sensor Error

Recommended Action

Per FDA guidance

The following actions are to be taken: 1. Use of the Phadia" 1000 can continue as detailed in the users manual with the following changes: If the error 7-102 occurs, ensure that the error is handled as stated below: A. Select Retry if the error occurs outside of Assay run. This selection has no effect on assay performance in this situation. B. Select Retry if the error occurred within Assay run in the previous six minutes. This selection has no effect on assay performance in this situation. Note: If you are unsure of the six minutes related to the error occurrence, select Stop. C. Select Stop if the error occurred within Assay run after six minutes as indicated in the system software. Note: Performing a Retry or Stop after six minutes presents a risk that assay performance and results are affected. Selecting Stop will stop ImmunoCAP dispensing and all processing tests will be flagged as erroneous. Corrective actions can then be performed. 2. Whether you select Retry or Stop, contact Technical Support after attending to error 7-102 according to the instructions above to provide notification to our technical department and to receive additional guidance. Additionally; Ensure that the sound alarm is audible and that the visible alarm is visible within the laboratory. Ensure that the criteria according to the user manual for incoming water (rinse solution) is met. Further, it is recommended to ensure that Monthly Maintenance with 1% Sodium Hypochlorite (bleach) solution is performed according to the user manual. Ensure Rinse and Wash Bottle Float/Stems are correctly installed in their respective bottles and are refilled in a timely manner when the instrument is operated. Ensure Stop Solution bottles are full at the start of Assay run, otherwise switch bottle connector to second bottle loaded prior to the first becoming empty. Note: Stop Solution bottles contain 1200 doses. If you have any questions, please