Changeflow GovPing Healthcare & Life Sciences B·R·A·H·M·S PlGF Plus Kryptor Safety Notice - A...
Urgent Enforcement Amended Final

B·R·A·H·M·S PlGF Plus Kryptor Safety Notice - ANSM R2609954

Favicon for ansm.sante.fr ANSM Drug & Device Safety Alerts
Detected
Email

Summary

ANSM has published a safety notice (ref. R2609954) regarding a safety action implemented by Brahms (Thermo Fisher Scientific) on the B·R·A·H·M·S PlGF Plus Kryptor diagnostic reagent used in medical biology laboratories. The safety action letter, dated 24/04/2026, has been distributed to affected users. ANSM directs inquiries to the manufacturer Brahms directly.

Published by ANSM on ansm.sante.fr . Detected, standardized, and enriched by GovPing. Review our methodology and editorial standards .

About this source

ANSM is France's national medicines and medical devices safety agency. Its safety information page publishes drug recalls, medical device field safety notices, batch withdrawals, and benefit-risk reassessments for products on the French market. Around 100 alerts a month, written in French. Many of the affected products are also sold across the EU and UK, so an ANSM recall often previews a wider regulatory response from the EMA, MHRA, BfArM, or AIFA in the days that follow. Watch this if you manufacture or distribute medical devices in Europe, run a hospital pharmacy network, or track post-market safety signals across the European market. Recent recalls include Monnal T60 ventilators, Murex HBsAg reagents, and Arrow Teleflex hemodialysis catheters.

What changed

ANSM published a safety notice informing medical biology laboratories of a safety action taken by Brahms (Thermo Fisher Scientific) regarding the B·R·A·H·M·S PlGF Plus Kryptor diagnostic reagent. The safety action is registered under ANSM reference number R2609954. Affected laboratory users have received a letter from Brahms with details of the action, and the PDF of the manufacturer's letter dated 24/04/2026 is available for download.

Medical biology laboratories that use B·R·A·H·M·S PlGF Plus Kryptor reagents should obtain and carefully review the manufacturer's letter (available via ANSM). They should direct all questions regarding this safety action to Brahms (Thermo Fisher Scientific) and follow any instructions provided in the manufacturer's communication.

Scheduled event

Date
2026-04-24

Archived snapshot

Apr 24, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

Information n° R2609954 destinée aux laboratoires d'analyses de biologie médicale L'ANSM a été informée de la mise en œuvre d’une action de sécurité effectuée par la société Brahms (Thermo Fisher Scientific)

Les utilisateurs concernés ont reçu le courrier ci-joint.

Cette action de sécurité est enregistrée à l’ANSM sous le n° R2609954. Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité. Téléchargez le courrier de la société Brahms (24/04/2026)

Get daily alerts for ANSM Drug & Device Safety Alerts

Daily digest delivered to your inbox.

Free. Unsubscribe anytime.

About this page

What is GovPing?

Every important government, regulator, and court update from around the world. One place. Real-time. Free. Our mission

What's from the agency?

Source document text, dates, docket IDs, and authority are extracted directly from ANSM.

What's AI-generated?

The summary, classification, recommended actions, deadlines, and penalty information are AI-generated from the original text and may contain errors. Always verify against the source document.

Last updated

Classification

Agency
ANSM
Instrument
Enforcement
Branch
Executive
Source language
fr
Legal weight
Binding
Stage
Final
Change scope
Substantive

Who this affects

Applies to
Healthcare providers Medical device makers
Industry sector
3345 Medical Device Manufacturing
Activity scope
Diagnostic reagent safety Medical laboratory testing Product safety notification
Geographic scope
France FR

Taxonomy

Primary area
Medical Devices
Operational domain
Clinical Operations
Topics
Public Health Healthcare

Get alerts for this source

We'll email you when ANSM Drug & Device Safety Alerts publishes new changes.

Free. Unsubscribe anytime.

You're subscribed!