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Epredia

RICHARD-ALLAN SCIENTIFIC COMPANY · Model Dry Containers, Unassembled, Unlabelled Bulk Pack · UDI-DI 00673693084239

NNI
0
510(k) clearances
29
Adverse events
4
Recalls
328
Facilities

Description

The Dry Container portfolio is designed to provide the end-user with the flexibility of filling their own container with a specified fixative. These non-sterile containers are supplied unlabeled and unassembled. The Dry Containers do not expire, and storage temperature should be evaluated on an individual basis according to the reagent in which the container is filled.

Recalls

DateFirmReason
2026-03-09Milestone S.R.L.There is a possibility of reagent leakage from the specimen container.
2021-12-01MEDLINE INDUSTRIES, LP - NorthfieldProduct stored incorrectly in temperature controlled setting instead of refrigeration.
2016-03-03Dynarex CorporationExterior carton is mis-labeled as Sterile. Non-sterile, bulk specimen containers were packed in incorrect exterior carton.
2011-02-18Cardinal Health IncIn one lot of product (lot# 1091745), the label for the small version of the sock (catalog number 65652-123) was improperly used for the larger version of the product (65652-124)

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.