LONGHORN VACCINES AND DIAGNOSTIC: PrimeStore Molecular Transport Medium (PS-MTM), Model Numbers LH-1-2, LH-1-3, LH-1-4, LH-1-5, LH-1-5CC, LH-1-15CC - Product Usage: intended for stabilization, transportation, and inactivation of infectious unprocessed nasal washes, nasopharyngeal, oral/throat swabs* suspected of containing Influenza A virus RNA. PS-MTM is also intended for the stabilization, transportation, and inactivation of infectious unprocessed sputum samples suspected of containing Mycobacterium tuberculosis (MTB) DNA from human samples.

Recall number

Z-2952-2020

Recalling firm

LONGHORN VACCINES AND DIAGNOSTIC

Product

PrimeStore Molecular Transport Medium (PS-MTM), Model Numbers LH-1-2, LH-1-3, LH-1-4, LH-1-5, LH-1-5CC, LH-1-15CC - Product Usage: intended for stabilization, transportation, and inactivation of infectious unprocessed nasal washes, nasopharyngeal, oral/throat swabs* suspected of containing Influenza A virus RNA. PS-MTM is also intended for the stabilization, transportation, and inactivation of infectious unprocessed sputum samples suspected of containing Mycobacterium tuberculosis (MTB) DNA from human samples.

Status

Open, Classified

Initiated

2020-06-03

Posted

not on file

Terminated

not on file

Reason

The tubes may have been delivered to some users without labels. Users may not be able to identify the tubes without these labels. If samples stored or transported in tubes are tested on certain systems or come into contact with bleach they can produce cyanide gas. The solution in these tubes contains guanidine thiocynate and may put laboratory personnel at risk of exposure to cyanide gas when it comes into contact with bleach or reagents containing bleach.

Root cause

Error in labeling

Action

URGENT MEDICAL DEVICE CORRECTION notification letter dated 6/1/20 was distributed to the customer. Update on PrimeStore MTM (Molecular Transport Media) and guanidine thiocyanate. We are sending you this letter to notify you that PrimeStore MTM tubes may have been delivered to some users without labels. Users may not be able to identify the tubes as PrimeStore MTM tubes without these labels. If samples stored or transported in PrimeStore MTM tubes are tested on the Hologic Panther or the Hologic Fusion System or come into contact with bleach they can produce cyanide gas. The solution in these tubes contains guanidine thiocynate and may put laboratory personnel at risk of exposure to cyanide gas when it comes into contact with bleach or reagents containing bleach. The Hologic Panther and the Hologic Fusion System platforms have a built-in decontamination step post-run analysis. Currently the Hologic decontamination liquid contains bleach that creates a dangerous chemical reaction producing cyanide gas when mixed with guanidine thiocyanate, one of the components of PrimeStore MTM, lysis buffers and other sample collection devices. The same reaction may occur if the PrimeStore MTM media comes into contact with bleach or other reagents containing bleach. You should evaluate procedures in your laboratory to determine if there is a risk of the PrimeStore MTM media contacting bleach or reagents containing bleach, such as during routine cleaning or decontamination following a spill. Please process the inactivated samples in PrimeStore MTM on molecular diagnostics platforms that do not use or contain bleach, and dispose of all the waste by following your Laboratorys Waste Disposal Protocols for your routine nucleic acid extraction kits (for DNA or RNA) as the guanidine in PrimeStore MTM aligns with the percentage of guanidine in other lysis buffers. Should there be any accidental spills of inactivated samples in PrimeStore MTM tubes, please

Quantity

1,936,050

Distribution

Nationwide distribution including in the state of MD.

Lot, serial or model codes

Lot Numbers: 200421A 200421B E200427A E200427B E2000505B CN200423 CN200427

510(k) numbers

not on file

PMA numbers

not on file

Product code

QBD

Firm FEI

3011818318

Firm city

Bethesda

Firm state

MD

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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