The following documents are summary of some medical device safety information related to potentially hazardous cases. It only serves as a quick reference and in no way should be considered as exhaustive and up-to-date. Please refer to the source of information and your product supplier for details.
Listing of Recalls
- RECALL: Voluntary Recall of Clear & Simple Digital Pregnancy Test
- RECALL : Voluntary Recall Of Durex Real Feel Batch
- RECALL: Voluntary Recall of Limited Number of ACUVUE® Brand Contact Lenses
- RECALL: RESPIRONICS TRILOGY 100 VENTILATORS
- RECALL: ALL UNIMPLANTED Cochlear Nucleus CI500 cochlear implant range
Listing of Field Safety Notice
- September 2021 : Urgent Product Correction FA29SEP2021 ARCHITECT ARCHITECT System software v9.45/9.50
- September 2021 : FSCA LASW 21-02 Aptio by Inpeco and FlexLab Automation : Aptio Automation Firmware (FW) for the ADVIA Centaur XP/XPT Interface Module may lead, in specific and rare cases, to an incorrect association of test result(s) to sample ID.
- September 2021 : 2021-IGT-PUN-010 (FCO72300030) - Firmware Upgrade for Intuis System
- September 2021 : FSCA ACHC 21-14 ADVIA and Atellica UCFP carryover : Falsely Depressed Enzymatic Hemoglobin A1c Results due to Reagent Carryover from the Urinary/Cerebrospinal Fluid Protein (UCFP) Assay.
- September 2021 : Field-Corrective Action Notification 20001103083 : Digital Linear Accelerator - For service user: precautions to be taken when handling diode D1