Ortho-Clinical recalls VITROS Calibrator Kit 11 VANC Reagent Generation 50 with affected Assay Data Disk for delayed testing results. Fix by updating to newer software versions.
Ortho-Clinical is recalling VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation 50 with affected Assay Data Disk (ADD) for Data Release Versions 6215 through 6223. This causes delays in vancomycin testing results, which could impact patient care. Read more at govinfonow.com/recall/58571-ortho-clinical-vitros-calibrator-kit-11-vanc-reagent-delay-risk.
“Ortho-Clinical VITROS Calibrator Kit 11 VANC Reagent Delay Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58571-ortho-clinical-vitros-calibrator-kit-11-vanc-reagent-delay-risk. Based on FDA recall #Z-1664-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1664-2023%22&limit=1).
The FDA announced on April 14, 2023, that Ortho-Clinical Diagnostics, Inc. is recalling VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with an affected Assay Data Disk. The hazard is that the product is unavailable to calibrate VITROS Chemistry Products VANC Reagent, which results in a delay of testing.
How to tell if you have it
Brand: Ortho-Clinical
Product: VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with affected Assay Data Disk
Data Release Versions: 6215 through 6223
Product Code: 6801696
UDI-DI: 10758750006601
Lot Number: 1172
Expiration Date: 20-OCT-2023
Units affected: 132
The hazard
According to the FDA, the recalled calibrator kit is unavailable to calibrate VITROS Chemistry Products VANC Reagent, Generation (GEN) 50. This unavailability results in a delay of testing for users.
Context
GovInfoNow's records show Ortho-Clinical Diagnostics, Inc. has 53 other recalls on record since July 10, 2017. Other recent recalls include the Ortho-Clinical LAC Slides Recall (July 29, 2025) and the Ortho-Clinical VITROS Ca Slides Recall (July 9, 2025), both involving calibration failures.
How to tell if you have this one
Check if your VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 has an Assay Data Disk (ADD) with Data Release Versions (DRVs) 6215 through 6223. Product code 6801696 and lot number 1172 are associated with this recall.
Brand
Ortho-Clinical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify your VITROS system's software version matches the Data Release Version (DRV) of the Assay Data Disk. If it's 6215-6223, it's affected.
Update Software
Contact Ortho-Clinical to update to a newer Data Release Version (DRV) that resolves the calibration delay issue.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Nationwide Foreign: Brazil, Chile, Colombia” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 54 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1664-2023 (April 14, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1664-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.