Stago STA-Deficient VIII Plasma Recalled for Cross-Contamination Risk
Diagnostica Stago is recalling STA-Deficient VIII plasma due to a risk of sample-to-sample cross-contamination that may cause falsely increased factor VIII levels.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of harm (falsely increased factor VIII levels) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Diagnostica Stago, Inc. is recalling 3,225 units of STA-Deficient VIII, Product Code 00725. This immuno-depleted human plasma is intended for use in tests for the determination of factor VIII activity in plasma on STA-R and STA Compact analyzer platforms. The product was distributed nationwide.
The recall is due to a risk of sample-to-sample cross-contamination of Emicizumab for factor VIII assays on Stago instruments. This contamination may shorten clotting times, causing factor VIII levels to be reported as falsely increased.
Customers using the affected software versions should contact Stago Field Support for upgrades to the specified software levels to implement the necessary cleaning sequence.
The recalled product
- Product
- STA - Deficient VIII, Product Code: 00725. STA - Deficient VIII is an immuno-depleted human plasma intended for use in tests for the determination of factor VIII activity in plasma on STA-R and STA Compact analyzer platforms as follows: (A) STA-R Max, Product Codes: 58989…
- Manufacturer
- Diagnostica Stago, Inc.
- Affected units
- 3,225
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Diagnostica Stago, Inc.
See all →- ModerateDiagnostica Stago Recalls STA Staclot Protein S Reagent Due to QC Drift
FDA (Devices) · 2026-09-09
- HighStago D-dimer assay shows positive bias across entire analytical range
FDA (Devices) · 2026-03-25
- HighStago free protein S assay may underestimate normal range results
FDA (Devices) · 2026-03-11
- HighLucky Ice mouthwash recalled over insanitary conditions at a distribution center
FDA (Devices) · 2026-01-21
- HighD-Dimer test reagents recalled over potential underestimation of measured levels
FDA (Devices) · 2025-10-22
Same hazard · cross contamination
See all →- HighFDA Recalls Performance Pro Nitrile Gloves Due to Defects
FDA (Devices) · 2026-10-07
- HighFDA Recalls Defective Blue Nitrile Patient Examination Gloves
FDA (Devices) · 2026-10-07
- HighFDA Recalls Opportunity Pro Nitrile Gloves Due to Manufacturing Defects
FDA (Devices) · 2026-10-07
- ModerateSage Products Recalls Chlorhexidine Gluconate Cloth Due to Cross Contamination
FDA (Drugs) · 2026-09-09
- CriticalCetirizine Hydrochloride Tablets Recalled Due to Cross Contamination with Ranitidine
FDA (Drugs) · 2026-07-29
Similar recalls
- HighSTA R Max Analyzer Firmware Bug Produces Inaccurate Coagulation Test Results
FDA (Devices) · 2023-05-17
- ModerateAnti-Xa test kits recalled over potential contamination by fibrinogen reagents
FDA (Devices) · 2025-09-03
- ModerateDiagnostica Stago STA Satellite Analyzer Recalled for Incorrect INR Printouts
FDA (Devices) · 2012-11-14
- LowStago IVD Liquid Anti-Xa Recalled for Barcode Misreading
FDA (Devices) · 2014-09-24
- ModerateFibrinogen test kits recalled over potential cross-contamination in heparin assays
FDA (Devices) · 2025-09-03
- HighStago free protein S assay may underestimate normal range results
FDA (Devices) · 2026-03-11