The Recall Desk
HighFDA (Devices)·Z-2952-2020·Announced 2020-09-23

Longhorn PrimeStore Molecular Transport Medium Tubes Recalled for Cyanide Risk

Longhorn Vaccines and Diagnostic is recalling PrimeStore Molecular Transport Medium tubes because the solution may produce cyanide gas when exposed to bleach.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (cyanide gas generation) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Longhorn Vaccines and Diagnostic is recalling PrimeStore Molecular Transport Medium (PS-MTM) tubes, including model numbers LH-1-2, LH-1-3, LH-1-4, LH-1-5, LH-1-5CC, and LH-1-15CC. The product is intended for the stabilization, transportation, and inactivation of infectious unprocessed nasal washes, nasopharyngeal, and oral/throat swabs suspected of containing Influenza A virus RNA, as well as sputum samples suspected of containing Mycobacterium tuberculosis (MTB) DNA. The recall involves 1,936,050 units distributed nationwide, including in Maryland.

The recall was issued because the tubes may have been delivered to some users without labels, preventing identification of the product. More critically, the solution in these tubes contains guanidine thiocyanate. If samples stored or transported in these tubes are tested on certain systems or come into contact with bleach or reagents containing bleach, they can produce cyanide gas. This poses a risk of exposure to cyanide gas for laboratory personnel.

Users should identify any unlabelled tubes or tubes with the affected lot numbers (200421A, 200421B, E200427A, E200427B, E2000505B, CN200423, CN200427) and stop using them. Laboratory personnel should avoid exposing the solution to bleach or bleach-containing reagents to prevent the generation of cyanide gas.

The recalled product

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
Affected units
1,936,050

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

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

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically: