Diagnostica Stago STA Staclot Protein S Recall: QC Value Drift Risk
Diagnostica Stago recalls STA Staclot Protein S reagent lot 273074 due to potential QC value drift during 4-hour stability period. Affected units may give inaccurate test results.
Lower-risk recall
A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified
What happened, in plain English
Diagnostica Stago is recalling a specific lot of STA Staclot Protein S reagents because they may show QC value drift within the 4-hour stability period. This could lead to inaccurate test results if used without the drift being corrected. Read more at govinfonow.com/recall/843293-diagnostica-stago-sta-staclot-protein-s-recall-qc-value-drift.
Source Summary by GovInfoNow · govinfonow.com/recall/843293-diagnostica-stago-sta-staclot-protein-s-recall-qc-value-drift · Updated September 16, 2026 · FDA enforcement record: FDA #Z-3047-2026
Cite this page
“Diagnostica Stago STA Staclot Protein S Recall: QC Value Drift Risk.” GovInfoNow, updated September 16, 2026. https://govinfonow.com/recall/843293-diagnostica-stago-sta-staclot-protein-s-recall-qc-value-drift. Based on FDA recall #Z-3047-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3047-2026%22&limit=1).
Why it’s dangerous
The reagent may show QC value drift within its stated 4-hour stability period. This drift could cause the test results to be inaccurate, potentially leading to incorrect conclusions in diagnostic testing.
Who’s affected
Users of the STA Staclot Protein S reagent lot 273074 are affected. Laboratory personnel performing qualitative and quantitative factor tests are most at risk of inaccurate results.
How to tell if you have this one
Check for the model number 00746 and lot number 273074 on the reagent packaging. The expiration date is March 31, 2027.
- Brand
Diagnostica Stago- Category
Medical device
What to do — step by step
Check Reagent Lot Number
Look for lot number 273074 on the reagent packaging to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 16 states.
FDA distribution: “US Nationwide distribution in the states and territory of NJ, NY, NJ, VA, PA, FL, AL, GA, TN, OH, IL, MO, NE, TX, CO, UT, CA, PR.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, California, Colorado, Florida, Georgia, Illinois, Missouri, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Puerto Rico, Tennessee, Texas, Utah, Virginia.
Recall timeline
FDA published this recall 42 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- Added to GovInfoNow
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-3047-2026 (July 29, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3047-2026 to see it in context.
- Plain-language summary written by qwen3:4b on September 16, 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.