Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
STA SYSTEM CONROL N + P (ref. 00678) Recalled by Diagnostica Stago, Inc. Due to A positive bias was confirmed to exists on...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Diagnostica Stago, Inc. directly.
Affected Products
STA SYSTEM CONROL N + P (ref. 00678)
Quantity: 5,437
Why Was This Recalled?
A positive bias was confirmed to exists on the STA - Unicalibrator levels with STA - Deficient IX and STA - Deficient VIII when compared to the International Standard (IS) for factor VIII or IX. This bias is also observed on several External Quality Assessment (EQA) results.
Where Was This Sold?
This product was distributed to 42 states: AL, AK, AZ, AR, CA, CO, CT, FL, GA, HI, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NV, NJ, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, VT, VA, WA, WI, DC
About Diagnostica Stago, Inc.
Diagnostica Stago, Inc. has 25 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report