MaaT013 Fecal Microbiota Allogeneic Pool Rectal Suspension Recall
Summary
ANSM and Clinigen Healthcare France have initiated a precautionary recall of six lots of MaaT013 (fecal microbiota allogeneic pool, rectal suspension). The recall follows discovery of a donor selection process non-compliance where a donor meeting exclusion criteria was included in stool collections used to manufacture the affected lots. Healthcare establishments holding affected lots (7P010/2410111, 7P010/2410092, 7P010/2410096, 7P010/2410109, 7P010/2503009, 7P010/2503012) should quarantine and return product to the manufacturer.
What changed
Clinigen Healthcare France, in coordination with ANSM, initiated a precautionary recall of six lots of MaaT013 fecal microbiota product following identification of a non-compliance in the donor selection process. A donor who met exclusion criteria was erroneously included in stool collections used to manufacture these lots. The affected lots carry expiration dates between July 2027 and March 2028.
Healthcare establishments that received these lots should immediately quarantine remaining stock and coordinate return with Clinigen Healthcare France using the provided contact information. No specific patient management actions beyond standard monitoring are required at this stage, as no patient impact has been reported. The recall was conducted directly with affected establishments without assignment of an alert number.
What to do next
- Quarantine affected lots of MaaT013 (lots 7P010/2410111, 7P010/2410092, 7P010/2410096, 7P010/2410109, 7P010/2503009, 7P010/2503012)
- Contact Clinigen Healthcare France at 01 57 32 32 23 or France@clinigengroup.com for return instructions
Archived snapshot
Apr 17, 2026GovPing 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.
Niveau de rappel : en direct auprès des établissements concernés Le laboratoire Clinigen Healthcare France procède, en accord avec l'ANSM et par mesure de précaution, au rappel des lots mentionnés ci-dessous de la spécialité :
MaaT013, microbiote fécal allogénique, pool, suspension rectale
- lot 7P010/2410111 (exp. 31/07/2027)
- lot 7P010/2410092 (exp. 17/10/2027)
- lot 7P010/2410096 (exp. 21/10/2027)
- lot 7P010/2410109 (exp. 29/10/2027)
- lot 7P010/2503009 (exp. 29/02/2028)
- lot 7P010/2503012 (exp. 03/03/2028)
Ce rappel fait suite à la mise en évidence d’une non-conformité concernant le processus de sélection d’un donneur impliqué dans les collectes de selles utilisées pour la fabrication de lots de MaaT013. Ce donneur a été inclus dans les collectes alors qu’il présentait un critère d’exclusion.
A ce stade, aucun impact ou action spécifique dans la gestion des patients n'est requise autre que la surveillance classique.
Ce rappel a été effectué en direct auprès des établissements concernés. Aucun numéro d'alerte n’a donc été attribué à ce retrait.
- Pour toute question relative à ce rappel de lots, veuillez contacter le service client de Clinigen Healthcare France au 01 57 32 32 23 ou par mail : France@clinigengroup.com
- Pour toute question d’information médicale, veuillez contacter Clinigen Healthcare France par téléphone au 04 81 68 23 30 ou par courriel à Medinfo-France@clinigengroup.com
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