Ortho-Clinical Diagnostics, Inc. recalls Brand Name: VITROS; Product Name: VITROS XT 7600 Integrated System; Model/Catalog Number: (1) 6844461, (2) 6272222; Software…
a software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the Use Expired Reagents setting is not enabled if a shelf expiration date…
Read the official notice →- Date
- 2025-07-09
- Country
- United States
- Brand
- Ortho-Clinical Diagnostics
- Product
- Brand Name: VITROS; Product Name: VITROS XT 7600 Integrated System; Model/Catalog Number: (1) 6844461, (2) 6272222; Software Version:…
- Classification
- Class II
- Units
- Worldwide Distribution: US (Nationwide) and OUS (International) to 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2025-08-27
USOrtho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products Ca Slides; Catalog Number: 145 0261;
Generations 67 and above of VITROS Ca Slides are experiencing an increased occurrence of Condition Code TH4-63J during calibration on VITROS XT 3400 and VITROS XT 7600 Systems, causing calibration failures that delay…
FDA · DeviceOrtho-Clinical Diagnostics, Inc.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice →- 2025-07-23
- US
Ortho-Clinical Diagnostics, Inc. recalls Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier I Model/Catalog Number: 806…
Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs when the PVs are used 2-7 days after reconstitution;…
FDA · DeviceOrtho-Clinical Diagnostics, Inc.Worldwide Distribution: US (nationwide) to states of: AZ, CA, FL, GA, IL, MD,…Official notice → - 2025-07-09
- US
Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITROS OP Reagent is a dual-chambered package…
Lots from Generation (GEN) 15 of VITROS Chemistry Products OP Reagent may generate lower than expected quality control (QC) results. If the customer is unable to get passing quality control results, then the customer…
FDA · DeviceOrtho-Clinical Diagnostics, Inc.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice → - US
Ortho-Clinical Diagnostics, Inc. recalls Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: (1) 6802413, (2) 6802915
A software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the Use Expired Reagents setting is not enabled if a shelf expiration date…
FDA · DeviceOrtho-Clinical Diagnostics, Inc.Worldwide Distribution: US (Nationwide) and OUS (International) to countries…Official notice → - 2025-06-18
- US
Ortho-Clinical Diagnostics, Inc. recalls Brand Name: Solana¿ Bordetella Complete Assay Product Name: Solana Bordetella kit Model/Catalog Number: M308 Software Version:…
It was determined that there could be a false positive rate of up to 16.7% for the affected lots associated with the Bordetella parapertussis (BPP) results (only) of the assay.
FDA · DeviceOrtho-Clinical Diagnostics, Inc.Please see the attached list "Consignee List_CL2025-120." Note: This file…Official notice → - 2025-06-04
- US
Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartridge, for a total of 90 slides.
Product was incorrectly assigned GEN 88 instead of GEN 83 on product carton, foil wrapper, and cartridge (cart) label.
FDA · DeviceOrtho-Clinical Diagnostics, Inc.Worldwide - US Nationwide distribution in the states of AR, AZ, CO, FL, GA,…Official notice →
Other drugs & medical recalls in the United States
- 2025-07-09
- US
MEDLINE INDUSTRIES, LP - Northfield recalls Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: 1) CC DRAWER 4 IV…
Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN which was identified that during insertion of the Catheter, the needle is slow…
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldUS Nationwide distribution in the states of IN, KY, CA, MI, TX, WA.Official notice → - US
Onkos Surgical, Inc. recalls My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Shoulder Arthroplasty Device
Required inspections were not performed on finished product prior to release and distribution.
FDA · DeviceOnkos Surgical, Inc.US Nationwide distribution in the state of Maryland.Official notice → - US
Hardy Diagnostics recalls HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. G323
Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae.
FDA · DeviceHardy DiagnosticsUS domestic distribution to the following states: AZ, CA, CO, FL, GA, IL, MD,…Official notice → - US
Ortho-Clinical Diagnostics, Inc. recalls Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: (1) 6802413, (2) 6802915
A software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the Use Expired Reagents setting is not enabled if a shelf expiration date…
FDA · DeviceOrtho-Clinical Diagnostics, Inc.Worldwide Distribution: US (Nationwide) and OUS (International) to countries…Official notice → - US
Philips Respironics, Inc. recalls BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients. BiPAP…
This device does not indicate for use in patients with respiratory failure.
FDA · DevicePhilips Respironics, Inc.Worldwide distribution: US (Nationwide)including Guam and Puerto Rico; OUS…Official notice → - US
Siemens Medical Solutions USA, Inc recalls interventional fluoroscopic x-ray system
In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high…