Z-2952-2020 Class II Ongoing

Recalled by LONGHORN VACCINES AND DIAGNOSTIC — Bethesda, MD

Recall Details

Product Type
Devices
Report Date
September 23, 2020
Initiation Date
June 3, 2020
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,936,050

Product Description

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.

Reason for Recall

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.

Distribution Pattern

Nationwide distribution including in the state of MD.

Code Information

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