FDA recall, , Moderate risk
Diagnostic Grifols Erytra Analyzer
The Erytra analyzer can assign incorrect results for an autocancelled and rescheduled test, potentially leading to an incident if a transfusion is performed.
Recall ended Oct 9, 2026. Still check yours.
Summary by Recall Canary from the FDA notice
What happened
Diagnostic Grifols, S.A. is recalling the Erytra analyzer, model 210400/210401, with software versions 4.5.0 and 4.6.0, because incorrect results can be assigned for an autocancelled and rescheduled test, potentially leading to an incident if a transfusion is performed. The recall began September 16, 2025, and was added to the FDA's Enforcement Report on October 9, 2026. Instruments with these software versions are distributed in 30 countries worldwide.
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?
Affected if its UPC or model number is listed.
A UPC is the number printed under a barcode.
Erytra, Model 210400/210401, Software versions 4.5.0 and 4.6.0
- UPC
- 08436583730935
- 4.5.0
- 4.6.0
- Recall number
- B-0011-2027
- Model number
- 210400/210401
Recall details
- Company began the recall
- Sold in
There are Erytra instruments with software version 4.5.0 or 4.6.0 installed in 30 countries worldwide.
- Company
- Diagnostic Grifols, S.A.
- Hazard
- Software defect
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 97627
- Recall number
- B-0011-2027
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
In FDA's weekly enforcement report
Listed on Recall Canary
