Ortho-Clinical Diagnostics VITROS DAT Performance Verifier IV Recall: Incorrect Storage
Ortho-Clinical Diagnostics recalls VITROS DAT Performance Verifier IV in vitro diagnostics due to incorrect storage labeling causing lower than expected BENZ results. Affected units have catalog #6802330 and lot #L5619.
Lower-risk recall
This product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers causing customers to obtain lower than expected VITROS BENZ results when using this control.
Contact the company
What happened, in plain English
Ortho-Clinical Diagnostics is recalling VITROS DAT Performance Verifier IV in vitro diagnostic products because improper storage labeling may cause lower than expected VIT: BENZ results. This could affect lab test accuracy if the product is used without proper storage. Read more at govinfonow.com/recall/72955-ortho-clinical-diagnostics-vitros-dat-performance-verifier-iv-recall-incorrect.
Source Summary by GovInfoNow · govinfonow.com/recall/72955-ortho-clinical-diagnostics-vitros-dat-performance-verifier-iv-recall-incorrect · Updated September 17, 2026 · FDA enforcement record: FDA #Z-0914-2018
Cite this page
“Ortho-Clinical Diagnostics VITROS DAT Performance Verifier IV Recall: Incorrect Storage.” GovInfoNow, updated September 17, 2026. https://govinfonow.com/recall/72955-ortho-clinical-diagnostics-vitros-dat-performance-verifier-iv-recall-incorrect. Based on FDA recall #Z-0914-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0914-2018%22&limit=1).
Why it’s dangerous
The product's storage labeling is incorrect for unopened units, which can lead to lower than expected VITROS BENZ results when used. This may cause inaccurate lab test outcomes if the product is not stored properly.
Who’s affected
Lab users who purchased VITROS DAT Performance Verifier IV in vitro diagnostics with catalog #6802330 and lot #L5619 are likely affected. Healthcare professionals using these products for lab testing are at the highest risk.
How to tell if you have this one
Check for catalog number 6802330 and lot number L5619 on the product label. This VITROS DAT Performance Verifier IV in vitro diagnostic was sold by Ortho-Clinical Diagnostics.
- Brand
Ortho-Clinical Diagnostics- Category
Medical device
All 5 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Worldwide distribution: US Nationwide (including Puerto Rico), Bermuda, Australia, Brazil, Canada, Chile, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain, Poland, and Russia.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0911-2018 | VITROS Chemistry Products DAT Performance Verifier I in vitro diagnostic; Catalog# 6802327 Lot# H5616 | 349 |
| Z-0912-2018 | VITROS Chemistry Products DAT Performance Verifier II in vitro diagnostic; Catalog# 6802328 Lot# J5617 | 323 |
| Z-0913-2018 | VITROS Chemistry Products DAT Performance Verifier III in vitro diagnostic; Catalog# 6802329 Lot# K5618 | 180 |
| Z-0914-2018 | VITROS Chemistry Products DAT Performance Verifier IV in vitro diagnostic; Catalog# 6802330 Lot# L5619 | 196 |
| Z-0915-2018 | VITROS Chemistry Products DAT Performance Verifier V in vitro diagnostic; Catalog# 6802331 Lot# M5620 | 102 |
What to do — step by step
Check Storage Label
Verify the product's storage label for correct labeling as per the manufacturer's instructions.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution: US Nationwide (including Puerto Rico), Bermuda, Australia, Brazil, Canada, Chile, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain, Poland, and Russia.” 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 terminated this recall 2.9 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
What should I do if I have this product?
Check the product's catalog number (6802330) and lot number (L5619) to confirm if it is affected. No specific action is required beyond checking the label.
Is there a risk of serious injury from this product?
The recall is for potential inaccurate lab results, not a physical safety hazard. There is no risk of serious injury.
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Where this comes from
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-0914-2018 (September 22, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0914-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 17, 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.