Ortho-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.
Read the official notice →- Date
- 2024-03-13
- Country
- United States
- Brand
- Ortho-Clinical Diagnostics
- Product
- VITROS 5600 Integrated System (New and Refurbished)
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the countries of Australia,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2024-06-12
USOrtho-Clinical Diagnostics, Inc. recalls VITROS Immunodiagnostic Products Vitamin B12 Range Verifier - In vitro diagnostic use ly. For use in verifying the calibration…
The results generated by the VITROS Immunodiagnostic Products Vitamin B12 Range Verifier Lot# 1200 RV Level 2 may cause range verification failure. The issue is detectable by the user when the product fails to meet the…
FDA · DeviceOrtho-Clinical Diagnostics, Inc.Worldwide - US Nationwide and the country of Columbia.Official notice →- 2024-04-03
- US
Ortho-Clinical Diagnostics recalls VITROS Performance Verifier I
The issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifier I and II. This issue has the potential to cause erroneous Quality Control (QC) results that could lead to testing…
FDA · DeviceOrtho-Clinical DiagnosticsWorldwide distribution - US Nationwide and the countries of Australia,…Official notice → - 2024-03-13
- US
Ortho-Clinical Diagnostics, Inc. recalls VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.
FDA · DeviceOrtho-Clinical Diagnostics, Inc.Worldwide - US Nationwide distribution in the states of AZ, CA, CT, FL, IA,…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 → - 2023-12-20
- US
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…
Other drugs & medical recalls in the United States
- 2024-03-13
- US
Synthes (USA) Products LLC recalls Opal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenerative spine disease Part Number: 08.803.231S
Products not sterilized, sterility cannot be confirmed
FDA · DeviceSynthes (USA) Products LLCWorldwide distribution - US Nationwide and the countries of Argentina,…Official notice → - US
Ortho-Clinical Diagnostics, Inc. recalls VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.
FDA · DeviceOrtho-Clinical Diagnostics, Inc.Worldwide - US Nationwide distribution in the states of AZ, CA, CT, FL, IA,…Official notice → - US
CareFusion 303, Inc. recalls BD Pyxis: MedStation ES, REF: 323; Anesthesia Station ES, REF: 327; MedStation ES Tower, REF: 352;
Automated dispensing cabinets, running affected software, and Windows 10 operating system may experience the application randomly hang, freeze and/or crash, which may result in delays in medication access, and…
FDA · DeviceCareFusion 303, Inc.Worldwide distribution - US Nationwide distribution including in the states of…Official notice → - US
Avanos Medical, Inc. recalls MIC* Gastric-Jejunal Feeding Tube with ENFit Connectors: a) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connector -…
MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist.
FDA · DeviceAvanos Medical, Inc.Worldwide distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CO,…Official notice → - US
Stason Pharmaceuticals, Inc. recalls Mercaptopurine Tablets, USP 50 mg, packaged in: a) 25-count bottle (NDC 69076-913-02), b) 250-count bottle (NDC 69076-913-25), Rx…
Failed Dissolution Specifications: results slightly under spec at at 9-months.
- US