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Epredia

RICHARD-ALLAN SCIENTIFIC COMPANY · Model Flex 95 · UDI-DI 00673693556705

PPM

510(k) clearances

316

Adverse events (1 deaths)

Recalls

259

Facilities

Description

Signature Series Flex is a patented dehydrating reagent specifically designed for processing and staining of histological and cytological tissue specimens. Flex is a clear, colorless blend of isopropyl and methyl alcohol. It is a non-controlled substance and does not require record keeping. Flex is available in concentrations of 80%, 95% and 100%. It is readily miscible with water to form any desired grade of alcohol. Flex is miscible with all clearing reagents. Studies have indicated that Flex does not over-dehydrate small tissue specimens as rapidly as ethyl and isopropyl alcohol, when used in accordance with the processing guidelines developed for Flex. The absence of over-dehydration during tissue processing allows for consistent results with both large and small tissue specimens. Flex can be used in tissue processing, staining and as a dye or stain solvent in place of ethyl alcohol. Flex can be used in all special stains that require dehydration in ethyl alcohol and in immunohistochemical reactions that are compatible with alcoholic dehydrants. Flex has been proven to produce brilliant hematoxylin and eosin stains, with crisp nuclear detail when used within designated guidelines. Flex is compatible with both open and closed tissue processors. Flex is a flammable product and must be stored in a flammable fire cabinet.

Recalls

Date	Firm	Reason
2026-03-26	Immuno-Mycologics, Inc	Neutralization Buffer may contain contaminants
2025-11-03	GET TESTED INTERNATIONAL AB	Distribution without premarket approval/clearance.
2025-10-29	Copan Italia	Treatment reagent functionality in respiratory specimens fluidification cannot be guaranteed.
2025-10-29	Copan Italia	Treatment reagent functionality in respiratory specimens liquification cannot be guaranteed.
2025-05-21	Diagnostica Stago, Inc.	Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1%
2025-04-24	Mckesson Medical-Surgical Inc. Corporate Office	transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failur
2024-09-25	Biocare Medical, LLC	Kits containing the DAB chromogen buffer, intended for use in either manual or automated Immunohistochemistry (IHC) staining protocols, may produce weak to no staining, which may l
2024-05-21	Ortho-Clinical Diagnostics, Inc.	VITROS Chemistry Products FS Diluent Pack 3, Lot 01-1645 may cause results to be negatively biased when used to dilute patient samples tested with VITROS Chemistry Products CRP Sli
2024-02-07	Beckman Coulter, Inc.	On 07 February 2024 Beckman Coulter made the decision to conduct a field action on Access Substrate (81906) lots: 234600, 337984, 338040, 338214, 338229, 338289, 338322, 338333, 33
2023-05-24	NeuMoDx Molecular Inc	Top label on some of the NeuMoDx cartridges within these lots may have been incorrectly applied during the manufacturing process, resulting in encroachment into the PCR region. The

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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.