Ortho-Clinical Diagnostics, Inc recalls VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198
Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immunodiagnostic Products FSH, LH and Prol Reagents Low End Imprecision. Low-level quality control (QC) and patient samples at…
Read the official notice →- Date
- 2022-05-25
- Country
- United States
- Brand
- Ortho-Clinical Diagnostics
- Product
- VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198
- Classification
- Class II
- Units
- Worldwide Distribution: US (Nationwide) OUS (Foreign): Australia Bermuda…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2022-11-16
USOrtho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products Calibrator Kit 9 -(GEN) 22 of VITROS PHYT Slides For in vitro diagnostic use only. Product Code:…
Calibration disk Data Release Version (DRV) 6194 to 6200 contain inappropriate calibration mathematics for VITROS Calibration Kit 9 for calibrating VITROS PHYT Slides, for all lots of slide generation 22 (GEN 22). The…
FDA · DeviceOrtho-Clinical Diagnostics, Inc.Worldwide Distribution: US (Nationwide) and Countries (Foreign) including:…Official notice →- 2022-09-14
- US
Ortho-Clinical Diagnostics, Inc. recalls VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: 6844461
Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED used in conjunction with the Digital Imaging Reflectometer.…
FDA · DeviceOrtho-Clinical Diagnostics, Inc.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice → - 2022-07-20
- US
Ortho-Clinical Diagnostics, Inc. recalls Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS¿ ECi/ECiQ/3600 Immunodiagnostic Systems and VITROS¿…
On-Analyzer Stability (OAS) time, supported for 6 weeks; not 8 weeks as is currently stated in the Instructions For Use (IFU).
FDA · DeviceOrtho-Clinical Diagnostics, Inc.Worldwide distribution - US Nationwide and the countries of Colombia, India,…Official notice → - 2022-03-16
- US
Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of 1000 tips per box.
The lot has a shape deformity which may lead to a 16% reduction in the volume of the sample or reagent dispensed. In cases where the error is not detected and the affected results are not suppressed, clinical impact…
FDA · DeviceOrtho-Clinical Diagnostics, Inc.Domestic distribution nationwide. Foreign distribution to Canada.Official notice → - 2022-01-26
- US
Ortho-Clinical Diagnostics, Inc. recalls VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack
Lower than expected results for VITROS¿ Immunodiagnostic Products TSH Reagent Pack when diluted with VITROS¿ Immunodiagnostic Products High Sample Diluent A Reagent Pack Lot 2190.
FDA · DeviceOrtho-Clinical Diagnostics, Inc.Worldwide distribution - US Nationwide distribution in the states of AL, AR,…Official notice → - 2021-11-24
- US
Ortho-Clinical Diagnostics, Inc. recalls VITROS Immunodiagnostic Products Anti-HBc IgM Controls, Product Code 6801427 For use in monitoring the performance of the VITROS…
Ortho Clinical Diagnostics confirmed a complaint that some VITROS Immunodiagnostic Products Anti-HBc IgM Controls Lot 1690 Controls Values booklet contained information for the incorrect product. While the accuracy of…
FDA · DeviceOrtho-Clinical Diagnostics, Inc.US (Domestic) distribution to states of: AZ, CA, CO, CT, FL, GA, LA, MA, MO,…Official notice →
Other drugs & medical recalls in the United States
- 2022-05-25
- US
Caire, Inc. recalls CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3
The device was not cleared for U.S. distribution.
FDA · DeviceCaire, Inc.Distribution was made to Puerto Rico. There was no foreign/government/military…Official notice → - US
Olympus Corporation of the Americas recalls Olympus Uretero-reno videoscope, Model No. URF-V2
The bending section of the URF-V2 may crack, resulting in an abnormal shape or abnormal angulation of the bending section.
FDA · DeviceOlympus Corporation of the AmericasUS Nationwide distribution in the state of AZ.Official notice → - US
Radiometer Medical ApS recalls Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU electrolyte-balanced heparin. Not for injection. , IVD, Rx Only,…
Arterial Blood Sampler sterility cannot be guaranteed throughout the shelf life of the product.
FDA · DeviceRadiometer Medical ApSWorldwide distribution - US Nationwide distribution in the states of AZ, CA,…Official notice → - US
TURBETT SURGICAL, LLC recalls Turbett Surgical Container, TS1500
Eight units manufactured before June 2019 have exhibited weld failures breaching the sterile barrier after prolonged use.
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Medtronic Inc recalls Instructions for Use, Patient Manuals, and Emergency Responder Guides for HeartWare Ventricular Assist Device (HVAD) System. HVAD System.…
Errors and inconsistencies that were identified in the Instruction for Use (IFU), Emergency Responder Guide (ERG), and Patient Manual (PM) for the HeartWare Ventricular Assist Device (HVAD) system.
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Luminex Corporation recalls VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021
Higher than normal "No Call Internal Control failures" due to a missing reagent within a small subset of the extraction tray lot.