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MGB Alert 2X ELITaq Master Mix, 48rxn

Elitechgroup Mdx LLC · Model M800809 · UDI-DI 03661540952517

PPM

510(k) clearances

315

Adverse events (1 deaths)

Recalls

259

Facilities

Description

The MGB Alert ELITaq Master Mix is a premixed ready-to-use solution containing necessary components and reaction buffer for efficient amplification of DNA templates by PCR. The solution is supplied at 2X relative to the optimal final concentration in the PCR, and contains 2X reaction buffer, dNTPs, MgCl2, and DNA polymerase with 5’ - 3’ exonuclease activity. PCR grade water is also provided in the product.

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.