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BOND

LEICA BIOSYSTEMS NEWCASTLE LTD · Model AR9551 · UDI-DI 05055331316554

PPM Prescription

510(k) clearances

315

Adverse events (1 deaths)

Recalls

259

Facilities

Description

BOND Enzyme Pretreatment Kit consists of an enzyme concentrate and an enzyme diluent, which require mixing, and is intended for enzymatic digestion of sections of formalin fixed, paraffin-embedded tissue using the automated BOND system (includes BOND-MAX, BOND-III, and BOND-PRIME systems).

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.