Z-2952-2020 Class II Ongoing
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