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;…
Read the official notice →- Date
- 2025-07-23
- Country
- United States
- Brand
- Ortho-Clinical Diagnostics
- Product
- Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier I Model/Catalog Number: 806 7324…
- Classification
- Class II
- Units
- Worldwide Distribution: US (nationwide) to states of: AZ, CA, FL, GA, IL, MD,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2025-09-24
USOrtho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges of 18 slides, for a total…
VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencing an increased occurrence of calibration failure related to lots from coating 0130 and above with Condition Code TH4-63J…
- 2025-08-27
- US
Ortho-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 → - 2025-07-09
- 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 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…
FDA · DeviceOrtho-Clinical Diagnostics, Inc.Worldwide Distribution: US (Nationwide) and OUS (International) to countries…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 →
Other drugs & medical recalls in the United States
- 2025-07-23
- US
Medtronic, Inc. recalls Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Azure…
A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eliminates the potential display of an erroneous electrical reset (pop-up) message upon interrogation with a…
- US
Encore Medical, LP recalls Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 12MM, VE Model/Catalog Number: 341-12-711…
Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could result in a revision surgery if used.
FDA · DeviceEncore Medical, LPU.S Distribution to states of: AZ, IA, ID, IL, IN, LA, MI, MO, MS, NE, NY, OK,…Official notice → - US
Microbiologics Inc recalls KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L
Affected products contain Staphylococcus epidermidis instead of the expected Brevundimonas diminuta. This may cause the user's quality control to fail and delayed diagnosis for the patient.
FDA · DeviceMicrobiologics IncUS distribution to states of: Utah and Ohio; and OUS (International) to…Official notice → - US
Waismed Ltd. recalls Brand Name: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000908 Software Version: N/A Product Description:…
Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.
FDA · DeviceWaismed Ltd.Worldwide distribution: US (nationwide) to state of: NC and OUS…Official notice → - US
ICU Medical, Inc. recalls SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF: SCXT3-2000
Due to a manufacturing issue, disinfecting cap for needle-free connectors may have an incomplete seal between the foil lid and plastic container, which may result in isopropyl alcohol evaporation from the sponge, which…
FDA · DeviceICU Medical, Inc.Worldwide - US Nationwide distribution including in the states of TX, SD, ID,…Official notice → - US
Beckman Coulter, Inc. recalls Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850
Beckman Coulter has received complaints of erroneous Vitamin B12 results when using Access Vitamin B12 Reagent lot 439850. The affected reagent lot may cause erroneously low or high Vitamin B12 results, leading to a…
FDA · DeviceBeckman Coulter, Inc.International distribution to the country of Andorra, Bulgaria, Denmark,…Official notice →