Recall Z-2397-2019 ยท DHB System, Test, Radioallergosorbent (Rast) Immunological
Phadia Ab
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.
| Date | Jul 9, 2019 |
| Status | Terminated |
| Reason | code 7-102 Liquid Sensor Error |
| Root cause | Under Investigation by firm |
| Action | 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 Sto |
| Quantity | 387 Instruments |
| Distribution | US Nationwide Distribution in the states of CA CO FL GA HI IL IN KS KY MA MD MI MO NC NJ NV NY OH OK OR PA TN TX UT VA WA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051218 | MODIFICATION TO: UNICAP SPECIFIC IGE Pharmacia Diagnostics AB, Jun 9, 2005 |