Reported Oct 14, 2026 · Terminated
Erytra Automated Blood Grouping and Antibody Test System, Templates Pack versions 15.0.0 and 16.0.0, Model no. 210400,…
Diagnostic Grifols, S.A.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Diagnostic Grifols, S.A. · Passeig Fluvial 24 · Parets Del Valles
Is this the product you have?
- Erytra Automated Blood Grouping and Antibody Test System, Templates Pack versions 15.0.0 and 16.0.0, Model no. 210400, 210401
- Lot codes and dates
- Model no 210400/210401
- UDI08436583730935, Templates Pack versions 15.0.0 and 16.0.0. Serial No. 059-0001686
- Amount recalled
- 1 instrument
Where it was sold
Why it was recalled
Diagnostic Grifols S.A has identified an issue in the technique definition for serial titration of antibodies using distributed DG Gel 8 Neutral cards, as configured in Templates Pack versions 15.0 and 16.0 for the U.S. market. This incorrect configuration can lead to minor variations in titration results (up to 1 titre), which remains within the generally accepted variability for semi-quantitative titration techniques. The potential affected products are Automated Blood Grouping and Antibody Test System 210400 Erytra and 210600 Erytra Eflexis.
This product could cause temporary or reversible health problems — stop using it.
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