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Recall Observatory FDA recall evidence

Device 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.

Z-2952-2020

June 03, 2020

Class II

Product summary

Firm
LONGHORN VACCINES AND DIAGNOSTIC
Event
Event 86189
Status
Ongoing
Classification
Class II
Quantity
1,936,050
Official record key
device-enforcement:Z-2952-2020

Official wording

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.

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

Distribution pattern: Nationwide distribution including in the state of MD.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.