medical Class II Updated 2020-09-23

LONGHORN VACCINES AND DIAGNOSTIC recalls PrimeStore Molecular Transport Medium (PS-MTM), Model Number

Recalled 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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Numbers: 200421A 200421B E200427A E200427B E2000505B CN200423 CN200427
View official government recall

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