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…
Read the official notice →- Date
- 2024-07-10
- Country
- United States
- Brand
- Ortho-Clinical Diagnostics
- Product
- VITROS Chemistry Products Calibrator Kit 29- In-Vitor used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT…
- Classification
- Class III
- Units
- Worldwide distribution - US Nationwide including Puerto Rico and the countries…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2024-08-28
USOrtho-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 →- 2024-08-21
- US
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…
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 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 → - 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 → - 2024-06-12
- US
Ortho-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 →
Other drugs & medical recalls in the United States
- 2024-07-10
- US
CareFusion 303, Inc. recalls BD Pyxis, Name/REF: MEDBANK MINI 1FH-1FM/ 169-137, MEDBANK MINI 1FH-2HH MEDPASS/ 169-151, MEDBANK MINI 1HH-1FH-1HM/ 169-101, MEDBANK MINI…
Multiple socket-outlet power strips that shipped with automated dispensing cabinet devices have not been certified to International Electrotechnical Commission (IEC) electrical standards when used as a system with…
FDA · DeviceCareFusion 303, Inc.US Nationwide distribution including in the states of NY, CA, MO, AZ, CO, KS,…Official notice → - US
Megadyne Medical Products, Inc. recalls Brand Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Reusable Patient Return…
To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient burns identified with use of Mega Soft pads.
FDA · DeviceMegadyne Medical Products, Inc.Domestic: Nationwide distribution International: AUSTRALIA, AUSTRIA, BAHRAIN,…Official notice → - US
First Source Inc recalls First Source Vision M. Portable cart and platform that supports an X-ray system and laptop computer.
Potential for the bolt that secures the positioning arm to the gas spring to come loose and fall onto patient.
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MicroPort Orthopedics Inc. recalls EVOLUTION¿ MP Femoral CS/CR Non-Porous Non-porous MicroPort total knee replacement implants are for cemented use only.
One confirmed incident has been received that EFSRN4PR, lot number MP1982170, Size 4 Evolution MP Non-Porous Femoral Right was opened during surgery and contained part number EFSRN3PL, lot number MP1982097, Size 3…
FDA · DeviceMicroPort Orthopedics Inc.International distribution in the country of China. There is no field…Official notice → - US
WOM World Of Medicine AG recalls WOM Tube Set for lrrlgatlon, single-use- Intended to transport irrigation fluid to the patient in endoscopic surgeries. Distr. by…
Incorrect transponder data was written on the RFID tags triggers the error message E03, Tube Set lnvalid, may result in a delay of surgery
- US
Siemens AG/Siemens Healthcare GmbH recalls ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional…
A potential issue with ARTIS icono systems equipped with a small detector and a corresponding collimator (model # 10843101) was identified. In very rare situations, the first x-ray release following patient…
FDA · DeviceSiemens AG/Siemens Healthcare GmbHWorldwide - US Nationwide distribution in the states of TX, MA, NH, MN, OK,…Official notice →