Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein (CRP) concentration in…
May Generate Negatively Biased Results When Testing Samples with High Concentrations of CRP, showing less than upper AMI of 90 mg/L (in the 70-90 mg/L range) while the samples having higher than 90 mg/L. User no way to…
Read the official notice →- Date
- 2024-12-04
- Country
- United States
- Brand
- Ortho-Clinical Diagnostics
- Product
- VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein (CRP) concentration in serum and…
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution in the states of AZ, FL, ID, IL, KS,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2025-01-29
USOrtho-Clinical Diagnostics, INc. recalls Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog Number: 6802783 (New), 6802914…
The VITROS 3600 Immunodiagnostic System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life expiration date. This could result in the use of expired…
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: 6844461 (New), 6272222 (Certified),…
The VITROS XT 7600 Integrated System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life expiration date. This could result in the use of expired…
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: 6802413 (New), 6802415…
The VITROS 5600 Integrated System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life expiration date. This could result in the use of expired…
FDA · DeviceOrtho-Clinical Diagnostics, INc.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice → - 2024-08-28
- US
Ortho-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 →
Other drugs & medical recalls in the United States
- 2024-12-04
- US
GE Healthcare (China) Co., Ltd. recalls GE Proteus XR/A radiographic system
Steel cables in the Wall Stand for certain Proteus XR/a systems serviced by GE HealthCare have not been replaced at the intervals detailed in the Preventative Maintenance Action List.
- US
INCIPIO DEVICES recalls Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants.
Recalled lot does not meet specification and has reported incidents of fracture of the TIG weld.
- US
Philips North America Llc recalls dS Breast 16ch 1.5T
Potential safety issue where a patient may be harmed while preparing for or during a scan.
- US
MEDLINE INDUSTRIES, LP - Northfield recalls (1) Medline Pacer Implant Pack, REF DYNJ59194A, 4 kits/case, sterile; and (2) Medline Thoracotomy Morristown, REF…
Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldUS Nationwide distribution in the states of AL, GA, MA, NJ, and PA.Official notice → - US
Boston Scientific Corporation recalls AMS Artificial Urinary Sphincter Control Pump
Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098)
FDA · DeviceBoston Scientific CorporationWorldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, KS,…Official notice → - US
Smiths Medical ASD, Inc. recalls smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP
Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube. This could lead to staining of the…