Phadia 1000 Instrument Recall: Retry Command Issue Affects Test Results
Phadia recalls its 1000 Instrument (Article 12-3800-01) due to a Retry command malfunction that may cause wash solution shortages and inaccurate test results. Affected users should contact Phadia for guidance.
Lower-risk recall
The "Retry" command does not function properly which could cause a shortage of Wash and Rinse solution and affect assay performance and test results.
Contact the company
What happened, in plain English
Phadia is recalling its 1000 Instrument (Article 12-3800-01) because the Retry command doesn't work properly. This could lead to shortages of wash and rinse solution and affect the accuracy of test results. Users should contact Phadia for instructions. Read more at govinfonow.com/recall/73459-phadia-1000-instrument-recall-retry-command-issue-affects-test-results.
Source Summary by GovInfoNow · govinfonow.com/recall/73459-phadia-1000-instrument-recall-retry-command-issue-affects-test-results · Updated September 21, 2026 · FDA enforcement record: FDA #Z-0387-2018
Cite this page
“Phadia 1000 Instrument Recall: Retry Command Issue Affects Test Results.” GovInfoNow, updated September 21, 2026. https://govinfonow.com/recall/73459-phadia-1000-instrument-recall-retry-command-issue-affects-test-results. Based on FDA recall #Z-0387-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0387-2018%22&limit=1).
Why it’s dangerous
The Retry command in the Phadia 1000 Instrument fails to function correctly, which may cause the instrument to run out of wash and rinse solution. This can lead to inaccurate test results if the instrument continues to operate without proper solution levels.
Who’s affected
Users of the Phadia 1000 Instrument with Article Number 12-3800-01 are affected. Laboratory staff and healthcare professionals who rely on this instrument for testing are most at risk.
How to tell if you have this one
Check for the Phadia 1000 Instrument with Article Number 12-3800-01. All versions of the instrument are affected, so no specific model or purchase date is required.
- Brand
Phadia- Category
Medical device
What to do — step by step
Contact Phadia
Reach out to Phadia directly for specific instructions on how to address the issue with your instrument.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 15 months 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.
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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-0387-2018 (July 5, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0387-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 21, 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.