FDA recall, , Moderate risk
Ortho-Clinical Diagnostics ORTHO VISION and ORTHO VISION Max Analyzers
Quidel Ortho is recalling the Ortho Vision and Ortho Vision Max Analyzers for ID-Micro Typing System (MTS) Gel Cards Software Version 5.16 and below for a software anomaly where the analyzer is unable to perform inventory of loaded reagents if the loading station door is opened immediately after the allotted 20-second countdown ends but within 0.2 seconds before to the door re-locks.
Recall ended Oct 13, 2026. Still check yours.
Summary by Recall Canary from the FDA notice
What happened
Quidel Ortho is recalling the ORTHO VISION Analyzer for ID-MTS Gel Cards (Product Code 6904577) and the ORTHO VISION Max Analyzer for ID-MTS Gel Cards (Product Code 6904576), Software Version 5.16 and below, for a software anomaly where the analyzer is unable to perform inventory of loaded reagents if the loading station door is opened immediately after the allotted 20-second countdown ends but within 0.2 seconds before the door re-locks.
The recall began on April 22, 2025, and was added to the FDA's Enforcement Report on March 25, 2026. The affected analyzers were distributed to 50 states, the District of Columbia, Canada, Colombia, Japan, Singapore, the United Kingdom, and Germany.
2 photos
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
3 products
Compare these details with yours, then check the recall notice to see which units are recalled.
Ortho Vision Max Analyzer for ID-MTS Gel Cards (Ortho Vision Max), Product Code 6904576, Version 5.16
Ortho Vision Analyzer for ID-MTS Gel Cards (Ortho Vision), Product Code 6904577, Version 5.16
Ortho Vision Analyzer for ID-MTS Gel Cards (Certified), Product Code 6153434, Version 5.16
- Affected units
- not provided; not distributed
Recall details
- Company began the recall
- Sold in
Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia, Wyoming, Canada, Colombia, Japan, Singapore, United Kingdom, and Germany
- Company
- Ortho-Clinical Diagnostics, Inc.
- Hazard
- Software defect
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 96842
- Recall numbers
- B-0030-2026, B-0041-2026, B-0042-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Recall ended
Listed on Recall Canary
