FDA recall, , Low risk
Diagnostic Grifols Erytra and Erytra Eflexis Automated Blood Grouping and Antibody Test Systems
The Erytra blood grouping system has an incorrect configuration that can cause minor variations in titration results.
Recall ended Oct 7, 2026. Still check yours.
Summary by Recall Canary from the FDA notice
What happened
Diagnostic Grifols, S.A. began a recall on March 9, 2026, for the Erytra Eflexis Automated Blood Grouping and Antibody Test System and the Erytra Automated Blood Grouping and Antibody Test System, due to an issue in the technique definition for serial titration of antibodies using distributed DG Gel 8 Neutral cards.
The incorrect configuration, as configured in Templates Pack versions 15.0 and 16.0 for the U.S. market, 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 affected products include the Erytra Eflexis system with Model no. 210600 and the Erytra system with Model nos. 210400 and 210401. The recall was added to the FDA's Enforcement Report and classified on October 7, 2026, and was in the FDA's weekly enforcement report on October 14, 2026. The instruments were updated for three customers in Alabama, Florida and Ohio.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
2 products
Affected if its UPC is listed.
A UPC is the number printed under a barcode.
Erytra Eflexis Automated Blood Grouping and Antibody Test System, Templates Pack versions 15.0.0 and 16.0.0, Model no. 210600
- UPC
- 08436583730942
- 15.0.0
- 16.0.0
Erytra Automated Blood Grouping and Antibody Test System, Templates Pack versions 15.0.0 and 16.0.0, Model no. 210400, 210401
- UPC
- 08436583730935
- 15.0.0
- 16.0.0
Recall details
- Company began the recall
- Sold in
There are Erytra and Erytra Eflexis instruments that has been update for three customers through the US. Customers including Alabama, Florida and Ohio.
- Company
- Diagnostic Grifols, S.A.
- Risk
Low risk
Taking it is unlikely to cause health problems.
FDA Class III recall · How risk is rated
- Event ID
- 98557
- Recall numbers
- B-0267-2026, B-0286-2026
All recalls from Diagnostic Grifols, S.A.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA · Recall ended
Listed on Recall Canary
In FDA's weekly enforcement report