Ortho Clinical Diagnostics Recalls
Showing 1-5 of 5 recalls
VITROS XT3400 Chemistry System, Product code 6844458
When processing MicroSlides, slides that utilize Slot 18 in the CM rotor may be mis-positioned. As a result, certain VITROS MicroSlides may produce erroneous results.
The firm notified customers through Urgent Product Correction Notification letters on July 20, 2020. Customers were informed of the potential issue with incubator slot 18 of affected devices. Customers were provided with a table of the eight assays with biases which do not align with the assay's intended clinical use. Customers who had already been identified as experiencing this issue through their e-connected systems, or who did not have e-connected systems, received a letter stating that the recalling firm would be replacing the CM Rotor to resolve the issue. Customers who had e-connected systems but who had not yet been identified as experiencing this issue were informed that Ortho would continue to monitor their system for an increase in the frequency of condition codes related to slide misalignment. If impacted, those customers would also receive a replacement CM Rotor. Customer actions: " If you suspect an erroneous result has occurred or you observe an increase in the frequency of TH4-60J/TH4-63J condition codes, contact Ortho Care Technical Solutions Center. " Review the enclosed Assay Observed Bias sheet for VITROS Slides assays used by your laboratory. Discuss any concerns with your Laboratory Medical Director. " Complete the Confirmation of Receipt form and return to the firm " Post this notification by each VITROS XT 3400 and/or XT 7600 System in your facility or with the user documentation.
VITROS 250 Chemistry System, clinical chemistry analyzer
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
Customers were notified prior to July 10, 2019. For the VITROS 250, 250AT, and 350 chemistry system: Do not use VITROS Calibrator Kit 32 to calibrate assays until an Ortho trained service personnel reconfigures your system(s) with the correct parameters for VITROS Calibrator Kit 32. Complete the enclosed Confirmation of Receipt form no later than July 15, 2019. Post this notification by each system that may use VITROS Calibrator Kit 32 until your system is reconfigured by an Ortho trained representative. Please forward this notification if the product was distributed outside of your facility. For the VITROS 4600,5600 and 5,1 FS chemistry System: If your system is configured with User Modified parameters, choose an option provided in the Interim Resolutions section listed above. Install ADD DRV 6040 or above upon availability. Complete the enclosed Confirmation of Receipt form no later than July 15, 2019. Post this notification either by each system that processes VITROS Calibrator Kit 32 or with your user documentation until DRV 6040 or above is installed on your system(s). Please forward this notification if the product was distributed outside of your facility. If you have further questions, please contact Ortho Care Technical Solutions Center at 1-800-421-3311.
VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Product Code: 6802783, Unique Identifier: 10758750002979
Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances
Ortho Clinical Diagnostics issued on 20 May 2020, Customer letter (Ref. CL2020-126) sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to all VITROS 3600, 5600 and XT7600 . Letter states reason for recall, health risk, and action to take: In the meantime, manually adding the values in both the serum screen AND the plasma screen (even though the plasma screen appears to be updated already) will prevent the issue by correctly marking the edits to both body fluids with M1. To manually enter these values for Plasma in Options & Configurations: navigate to Plasma, select the assay, select Review/Edit Configuration, edit Qualitative fields to match Serum. If it appears they currently match, retype at least one of the changes, then touch Save. Once the Qualitative Range values have been updated, load an ADD using Retain Configuration. Verify that both Serum and Plasma values match the intended modifications. This indicates that the modifications were marked with a M1 code and will continue to be retained when that option is used during future ADD loads. " A review of previously reported patient results is recommended if you identify an assay modification in which Serum and Plasma do not match. Review Plasma sample results for these assays versus your intended thresholds. Note: if your VITROS System is connected via e-connectivity, the Ortho Care Technical Solutions Center can assist you with obtaining your patient results from the past 90 days. " If you believe this software anomaly has affected sample results in your laboratory, please contact Ortho Care Technical Solutions Center. " Complete the Confirmation of Receipt form Foreign affiliates were informed by email approximately on 20 May 2020 of the issue and instructed to notify their consignees of the issue and required actions until the software mitigation is available. The anomaly will be resolved with software version
VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468
The specified reagent packs exhibit an increase in the frequency of unsuccessful calibrations.
IMPORTANT PRODUCT CORRECTION NOTIFICATION letters dated 3/10/20 were sent to customers. REQUIRED ACTIONS " If you have VITROS TT4 Reagent Packs Lot 2340 in your inventory, Ortho will replace or credit your account as indicated on your Confirmation of Receipt form. NOTE: As a reminder, if you have a successful calibration, and quality control results are acceptable, it is acceptable to continue using the affected lot. " Post this notification by each system that processes VITROS TT4 Reagent Packs, Lot 2340. " Complete the Confirmation of Receipt form now to register receipt of the notification. All customers should return the completed form by March 25, 2020. " If you are satisfied with the product at this time but want Lot 2340 replaced in the future, you may resubmit the Confirmation of Receipt form at that time, indicating the quantity that requires replacement. " In the event of future occurrences, retain a copy of the Confirmation of Receipt form and re-submit if needed. " Please forward this notification if the product was distributed outside of your facility. Contact Information We apologize for the inconvenience this will cause your laboratory. If you have further questions, please contact Ortho Care" Technical Solutions Center at 1-800-421-3311.
VITROS Anti-SARS-CoV-2 Total Reagent, COV2TOT, VITROS CoV2T. Catalog number 6199922, UDI 10758750033386 - Product Usage: Rx ONLY. For in vitro diagnostic and Laboratory Professional use. For emergency authorization use only.
The reagent bottles may be swapped within the reagent pack, which may lead to false negative results or delayed results due to calibration failures, or quality control failures.
On July 17, 2020, the firm issued Urgent Product Correction Notification letters to affected customers. Customers were informed of the potential for erroneous patient sample results, calibration errors, and QC failures when using the impacted product. Customers were asked to do the following; " Visually inspect affected VITROS Anti-SARS-CoV-2 Total (Lots 0010-0037) and IgG (Lots 0010-0013) Reagent Packs to ensure correct reagent bottle configuration " Set aside any pack in which the reagent bottles are positioned incorrectly, so the lot number and pack id can be provided to Ortho. Complete and submit the enclosed Request for Credit Form, including the pack information, to receive credit for an affected pack. " Complete the Confirmation of Receipt form no later than July 28, 2020. " Post this notification by each system that processes an affected lot. " Please forward this notification if the product was distributed outside of your facility. If you have questions, please contact Ortho Care Technical Solutions Center at 1-800-421-3311.