Ortho-Clinical Diagnostics, Inc. recalls VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.0
During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystems, unresponsive user interface (sometimes referred to as a screen…
Read the official notice →- Date
- 2023-12-20
- Country
- United States
- Brand
- Ortho-Clinical Diagnostics
- Product
- VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.0
- Classification
- Class II
- Units
- US Nationwide. Global Distribution.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Ortho-Clinical Diagnostics recalls
- 2024-03-13
USOrtho-Clinical Diagnostics, Inc. recalls VITROS 5600 Integrated System (New and Refurbished)
Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems which may lead to erroneous test results.
FDA · DeviceOrtho-Clinical Diagnostics, Inc.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice →- 2024-01-31
- US
Ortho-Clinical Diagnostics, Inc. recalls VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Products…
Affected lots may experience increased calibration failures or an increase in falsely elevated results.
FDA · DeviceOrtho-Clinical Diagnostics, Inc.Domestic distribution nationwide. OUS distribution to Bermuda, Australia,…Official notice → - 2024-01-17
- US
Ortho-Clinical Diagnostics, Inc. recalls QMS Tacrolimus Calibrators, Product code 10015573
Ortho-Clinical Diagnostics, Inc. is recalling QMS Tacrolimus Calibrators, Lot 74859619 expiry date: May 11, 2024, due to improper storage that is expected to degrade the quality of the calibrator and render it…
FDA · DeviceOrtho-Clinical Diagnostics, Inc.Domestic distribution to IL, IN, FL, NJ, NM, TX. International distribution to…Official notice → - 2023-12-13
- US
Ortho-Clinical Diagnostics, INc. recalls VITROS Chemistry Products ECO2 Slides-For in vitro diagnostic use only. VITROS Chemistry Products ECO2 Slides quantitatively…
Ortho Clinical Diagnostics (QuidelOrtho) confirmed during routine testing that some lots from Coating 3598 of VITROS ECO2 slides included carts which may contain consecutive slides that may not function as intended.…
- 2023-11-15
- US
Ortho-Clinical Diagnostics, INc. recalls VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749 (contains 18…
Products 1668409 and 8297749 may contain VITROS Lipase Slides with an abnormality which could cause -46% to +86% bias in lipase results depending on how the slides are used. Falsely low levels could result in a missed…
FDA · DeviceOrtho-Clinical Diagnostics, INc.US States: CA, CO, FL, GA, IL, IN, KS, NC, NY, TN, TX, VT. Canada, France,…Official notice → - 2023-10-11
- US
Ortho-Clinical Diagnostics, Inc. recalls Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Chemistry…
Ortho Clinical Diagnostics (QuidelOrtho) confirmed certain Proboscis/Piston Assemblies manufactured between 07-Apr-2022 (Date code: 040722) and 19-Dec-2022 (Date code: 121922) may not perform as intended due to an…
FDA · DeviceOrtho-Clinical Diagnostics, Inc.Worldwide - US Nationwide distribution.Official notice →
Other drugs & medical recalls in the United States
- 2023-12-20
- US
CHANGE HEALTHCARE CANADA COMPANY recalls Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS.
Under certain circumstances, information from HL7 messages received by Stratus PACS/Imaging Share systems has been incorrectly associated with another patient's study.
FDA · DeviceCHANGE HEALTHCARE CANADA COMPANYUS Nationwide distribution. There was no military/government distribution.Official notice → - US
Baxter Healthcare Corporation recalls Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479
There is to an increase in complaints related to failure alarms for Wet Cassette Integrity Test occurring on the Amia devices.
FDA · DeviceBaxter Healthcare CorporationWorldwide distribution - US Nationwide and the country of Canada.Official notice → - US
Integra LifeSciences Corp. recalls CereLink ICP Extension Cable (Extension Cable), Model No. 826845 Used with Codman CereLink Intracranial Pressure (ICP) Monitor, Model…
Firm is expanding the existing recall RES 90457 for the Cerelink, initiated in June 2022, to include all CereLink ICP Extension Cables. The updated corrective action includes a design change to the extension cable to…
FDA · DeviceIntegra LifeSciences Corp.US distribution nationwide to the following states: AL AR AZ CA CO CT DC DE FL…Official notice → - US
- US
Encore Medical, LP recalls RSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204. DJO Surgical shoulder device.
Coating hex did not engage with the Straight Mod Hexdriver or with the Hex Head Screw Driver
FDA · DeviceEncore Medical, LPU.S.: AZ, CA, FL, IN, KS, KY, ME, MN, MS, NJ, OH, Puerto Rico, RI, SC, TN, TX,…Official notice → - US
MEDLINE INDUSTRIES, LP - Northfield recalls STERILE PVP SOLUTION, REF DYNDA1907
The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile.
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldUS Nationwide distribution in the states of CT, IA, LA, MA, PA, CA, NY, FL.Official notice →