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.
Read the official notice →- Date
- 2024-07-10
- Country
- United States
- Brand
- Ortho-Clinical Diagnostics
- Product
- VITROS Chemistry Products FS Diluent Pack 3, Model/Catalog Number: 6801754. Product Description: VITROS Chemistry Products FS Diluent Pack…
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution in the states of FL, IL, NY, PA and the…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2024-12-04
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
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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 →- 2024-08-21
US
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FDA · DeviceOrtho-Clinical Diagnostics, Inc.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice →- 2024-07-10
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…
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US
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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 →- 2024-06-12
US
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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 →
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- 2024-07-17
US
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Angiodynamics, Inc. recalls IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100
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