Safety action on RAL Stainer bacteriology staining machines
France's medicines safety agency ANSM has been told of a safety action covering RAL Stainer and RAL TB Stainer bacteriology staining machines, carried out by I2A, Medical Overseas Pharma and Biomérieux. The action is logged under reference R2628220, and affected laboratories have received letters from the companies. The first notice dated 1 October 2026 was later updated with a Sysmex letter dated 3 November 2026.
This summary was generated by AI; the official source prevails.
What does it mean?
Laboratories that use these RAL automated staining machines to prepare samples for bacteria testing have been sent a safety letter. The notice does not say what the problem is, so labs should follow the instructions in the letter they received.
Who is affected?
Medical biology laboratories that use RAL Stainer or RAL TB Stainer machines.