Agilent Technologies, Inc. Recalls
Showing 1-3 of 3 recalls
Kit Label: Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-2 Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-21 Vial Labels: Mat. No K589911-21512
Label provided for substrate vail contained incorrect expiration date.
On 05/20/2022 and 05/27/2022, Agilent Technologies, Inc. had conference calls with the two Medical Laboratory Facilities that were distributed the affected product to inform them of the situation of the incorrect expiration date on the substrate vials (incorrect expiration dated of 6-30-22. The correct expiration date should be 4-30-22 Customer are instructed/informed: - To immediately cease using Anti-FITC-AP CISH Accessory Kit Lot Numbers 06586309 and 06646626, and to return any remaining labels to Agilent, and return any unused kits to Agilent. - That Agilent is completing production of a new lot of the Kit, and will be shipping to customers on Monday, 05/23/2022, to replace those expired kits. Kits will be provided Free of Charge. - To review test data/results from 05/01/2022 onwards as appropriate in accordance with their applicable procedures. On 06/10/2022, an "Urgent Product Removal" letter was emailed to customer informing them of the removal action. For any questions or further assistance, contact Agilent's Field Action Team at fieldactions@agilent.com
MassHunter Quantitative Analysis Software, Version B.07.01, used with Triple Quadrupole Mass Spectrometers, models K6460 and K6420 Product Usage: A mass spectrometer for clinical use is a device intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by ionizing the compound under investigation and separating the resulting ions by means of an electrical and magnetic field according to their mass.
When utilizing specific software versions of an LC/MS device, and Batch at a Glance in Compound Table view, a defect occurs when a new sample(s) is inserted. This defect creates a mismatch between the sample name and the column header whereby the sample header will be offset by one sample. The recalling firm requests that you discontinue using this workflow to generate reports because the Quant batch table will not display fully analyzed results or save any changes made.
On 08/13/18, Urgent Medical Device Recall notices were sent to customers informing them that the defect has been corrected with software version B.08.01. The recalling firm will contact customers to schedule the new software installation. Software version B.08.01 is being released in conjunction with software version B.08.03. This software suite includes improvements to other non-patient safety related defects such as the following fixes in Acquisition B.08.03. -Improvements to DMRM method setup which will prevent exceeding transition limits ("Failed to WriteScan" errors). Improvements to MassHunter Optimizer preventing intermittently missed entries that give "Phase 3Optimization" error.A full list of defects is contained in the Software Release Bulletin supplied with your software. Customers with additional questions were encouraged to call 1-866-488-4080. Customers were asked to complete and return an acknowledgement form.
Bond Elut OMS (Dried Matrix Spotting)' Product; Catalog model numbers: 5022-8226 - Auto DBS Card (LCMS Extraction Sys) 50 pk; A400150 - Bond Elut EMS Card 50/Pk; A400150K - Bond Elut DMS Card BULK 500/pk; A400150SK - Bond Elut DMS Card Starter Kit A42001 - Bond Elut MDS Card Accessory Pack Product Usage: For use in the analysis of dried blood spots and other biological matrices in research applications for drug metabolism pharmacokinetics/ absorption, distribution. metabolism and excretion (
The product was marketed without 510(k) clearance.
Agilent Technologies Letters via e-mail were sent to customers on June 17, 2015. Letters advised that the Bond Elut DMS Product was being withdrawn from the market.