Ortho-Clinical Diagnostics, Inc. recalls VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2
It was confirmed that fibrinogen in patient plasma samples precipitates out of solution upon the addition of folate stabilizer reagent as part of the pre-treatment process causing the increase in "TM5-4MB" condition…
Read the official notice →- Date
- 2024-08-21
- Country
- United States
- Brand
- Ortho-Clinical Diagnostics
- Product
- VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2025-01-29
USOrtho-Clinical Diagnostics, INc. recalls Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: 6802413 (New), 6802415…
The VITROS 5600 Integrated System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life expiration date. This could result in the use of expired…
FDA · DeviceOrtho-Clinical Diagnostics, INc.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice →- 2024-12-04
- US
Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein (CRP) concentration in…
May Generate Negatively Biased Results When Testing Samples with High Concentrations of CRP, showing less than upper AMI of 90 mg/L (in the 70-90 mg/L range) while the samples having higher than 90 mg/L. User no way to…
FDA · DeviceOrtho-Clinical Diagnostics, Inc.Worldwide - US Nationwide distribution in the states of AZ, FL, ID, IL, KS,…Official notice → - 2024-08-28
- US
Ortho-Clinical Diagnostics, Inc. recalls The VITROS XT Chemistry Products ALB-TP Slides is a single device that contains both an albumin test and a total protein test…
The reason for this recall is QuidelOrtho has determined that during normal use the VITROS XT ALB-TP Slides may shed dust and debris as they travel through the MicroSlide Subsystem of the VITROS XT 3400 or VITROS XT…
FDA · DeviceOrtho-Clinical Diagnostics, Inc.Nationwide. Foreign: Australia Belgium Bermuda Brazil Canada L3R 0B8 Chile…Official notice → - 2024-07-10
- US
Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products FS Diluent Pack 3, Model/Catalog Number: 6801754. Product Description: VITROS Chemistry Products FS…
VITROS Chemistry Products FS Diluent Pack 3, Lot 01-1645 may cause results to be negatively biased when used to dilute patient samples tested with VITROS Chemistry Products CRP Slides.
FDA · DeviceOrtho-Clinical Diagnostics, Inc.Worldwide - US Nationwide distribution in the states of FL, IL, NY, PA and the…Official notice → - US
Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products Calibrator Kit 29- In-Vitor used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS…
Kit assigned an extended expiration date of 24-Jul-2025 during release. The correct expiration date for Lot 2953 is 24-Jul-2024. If used past its true expiration and the customer does not have their Assay Data Disk…
FDA · DeviceOrtho-Clinical Diagnostics, Inc.Worldwide distribution - US Nationwide including Puerto Rico and the countries…Official notice → - 2024-06-19
- US
Ortho-Clinical Diagnostics, Inc. recalls VITROS Immunodiagnostic Products Anti HBs Calibrators. The VITROS Anti-HBs Calibrator Pack contains 3 X labelled Calibrator…
Potential for positively biased results due to signal reduction over shelf life.
FDA · DeviceOrtho-Clinical Diagnostics, Inc.Worldwide - US Nationwide distribution including in the states of AL, AR, AZ,…Official notice →
Other drugs & medical recalls in the United States
- 2024-08-21
- US
Becton Dickinson & Co. recalls BD Kiestra Urine Culture Application Powered by BD Synapsys Informatics Solution; Catalog (Ref): 444900;
There is a potential risk that the image colony count does not adequately reflect the actual plate colony count and may lead to inaccurate counts that would impact patient diagnosis and subsequent care.
FDA · DeviceBecton Dickinson & Co.US distribution to states of: CO, CT, IA, IL, KY, MD, MI, MN, NC, NJ, NY, OH,…Official notice → - US
Cepheid recalls Cepheid, Sample Collection Device, Part: 900-0370
Specimen collection device may leak after the patient sample swabs have been inserted into the test tubes, which could result in biohazard exposure, cross contamination causing false positive results for other…
FDA · DeviceCepheidWorldwide distribution: US (nationwide): IL, TX, OH, LA, NY, CA, MD, IA, MN,…Official notice → - US
Thoratec LLC recalls HeartMate 3 System Controllers provided within the following HeartMate 3 Left Ventricular Assist System (LVAS) Implant Kits or distributed…
Left ventricular assist system controller UI membrane/screen may lift along the edge of the controller housing, and if controller is exposed to fluid, ingress may occur, which may damage printed circuit board…
FDA · DeviceThoratec LLCUS: MN, PA, FL, IL, NY, DE, AR, NJ, NC, GA, WI, AZ, TN, MO, TX, MA, OH, VA,…Official notice → - US
Merit Medical Systems, Inc. recalls Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Rapid Response…
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
FDA · DeviceMerit Medical Systems, Inc.U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA,…Official notice → - US
Beckman Coulter, Inc. recalls Discrete photometric chemistry analyzer for clinical use.
Beckman Coulter, Inc. has identified a rise in reagent carousel motion errors in Access 2 Immunoassay System Analyzers that appear to be caused by misaligned index wheels housed within the reagent carousel module.…
FDA · DeviceBeckman Coulter, Inc.Worldwide - US Nationwide distribution in the states of NE, MT, LA, TX, NY,…Official notice → - US
Beckman Coulter, Inc. recalls Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.
The reason for this recall is Beckman Coulter has determined that when a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS); is running with the software versions 1.17 and below;…
FDA · DeviceBeckman Coulter, Inc.Worldwide distribution - US Nationwide distribution in the states of CA, FL,…Official notice →