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…
Read the official notice →- Date
- 2024-01-17
- Country
- United States
- Brand
- Ortho-Clinical Diagnostics
- Product
- QMS Tacrolimus Calibrators, Product code 10015573
- Classification
- Class II
- Units
- Domestic distribution to IL, IN, FL, NJ, NM, TX. International distribution to…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2024-03-13
USOrtho-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
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.
FDA · DeviceOrtho-Clinical Diagnostics, Inc.Worldwide distribution - US Nationwide and the countries of Australia,…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 → - 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…
- 2023-12-13
- US
Ortho-Clinical Diagnostics, INc. recalls VITROS Chemistry Products ECO2 Slides-For in vitro diagnostic use only. VITROS Chemistry Products ECO2 Slides quantitatively…
Ortho Clinical Diagnostics (QuidelOrtho) confirmed during routine testing that some lots from Coating 3598 of VITROS ECO2 slides included carts which may contain consecutive slides that may not function as intended.…
- 2023-11-15
- US
Ortho-Clinical Diagnostics, INc. recalls VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749 (contains 18…
Products 1668409 and 8297749 may contain VITROS Lipase Slides with an abnormality which could cause -46% to +86% bias in lipase results depending on how the slides are used. Falsely low levels could result in a missed…
FDA · DeviceOrtho-Clinical Diagnostics, INc.US States: CA, CO, FL, GA, IL, IN, KS, NC, NY, TN, TX, VT. Canada, France,…Official notice →
Other drugs & medical recalls in the United States
- 2024-01-17
- US
Philips North America recalls (1) Ingenia Ambition X (Product Number 781356); (2) Ingenia Ambition S (Product Number 781359)
The sealed magnet will experience uncontrolled shutdown known as Loss-of-Field (LoF) if the magnet loses cryo-cooling (e.g. caused by a power outage on site.)
FDA · DevicePhilips North AmericaDomestic distribution to the following states and territories: CA DE FL GA IL…Official notice → - US
Ambu Inc. recalls Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2
Instructions for Use have been updated to add the following warning: Use only M4 screws with the length of 14 16 mm when mounting Ambu aView 2 Advance on a VESA interface. Using longer screw lengths will penetrate the…
- US
mo-Vis BVBA recalls Scoot Control R-net, Product Number P015-61. The Scoot Control is intended to support a wheelchair attendant in controlling or maneuvering…
In rare cases, the lever of the throttle can get temporarily stuck during the movement and does not come back to its neutral point by itself. If this happens during usage, an unwanted movement of the chair could be the…
- US
MEDLINE INDUSTRIES, LP - Northfield recalls Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), REF SPT-2208CS, 100/pack, Non-Sterile.
Surgical gowns were manufactured with the wrong sleeve.
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldDistribution was made to MD, OH, TN, TX, and WI. There was no…Official notice → - US
Blue Belt Technologies, Inc recalls CORI REAL INTELLIGENCE Robotic Drill, Product No. ROB10013 and ROB10013S
Possibility that the user is unable to resolve drill disconnection error messages.
- US
Baxter Healthcare Corporation recalls XScribe CP Cardiac Stress Testing System, version 6, with below product names and codes: a) X-SCRIBE CPI KIT WIRELESS USB 608 MHz,…
Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled.
FDA · DeviceBaxter Healthcare CorporationUnited States (including Puerto Rico), Canada, Australia, Bangladesh, Brunei,…Official notice →