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Urgent Enforcement Amended Final

Epoc BGEM BUN Test Cards Recall R2611086 - Medical Biology Laboratories

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Summary

ANSM recorded safety action R2611086 after Epocal withdrew multiple lots of Epoc BGEM BUN Test Cards (boxes of 25 test cards) from medical biology analysis laboratories. The recalling firm has directly notified affected users. The safety alert is registered under ANSM reference R2611086. Laboratories in possession of the recalled product should contact Epocal directly for instructions.

“L'ANSM a été informée de la mise en œuvre du retrait de plusieurs lots effectué par la société Epocal.”

ANSM , verbatim from source
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 recorded a lot-based withdrawal of Epoc BGEM BUN Test Cards, initiated by the manufacturer Epocal. This recall affects medical biology analysis laboratories that use the Epoc blood gas testing system. Affected users have already received a notification letter from Epocal detailing the specific lots involved and recommended actions.

Laboratories that may have received the recalled product should treat this as an urgent patient-safety matter and contact Epocal immediately for disposition instructions. Quality and procurement teams should cross-reference lot numbers against their inventory records and halt use of any affected product pending further guidance from the manufacturer.

What to do next

  1. Contact Epocal directly for instructions regarding the recalled product

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.

Rappel n° R2611086 destiné aux laboratoires d'analyses de biologie médicale L'ANSM a été informée de la mise en œuvre du retrait de plusieurs lots effectué par la société Epocal.

Les utilisateurs concernés ont reçu le courrier ci-joint.

Cette action de sécurité est enregistrée à l’ANSM sous le n° R2611086. Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité. Téléchargez le courrier de la société Epocal (24/04/2026)

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Last updated

Classification

Agency
ANSM
Filed
April 24th, 2026
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
Medical device recall Laboratory testing products
Geographic scope
France FR

Taxonomy

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

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