Reported Sep 23, 2020 · Ongoing
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 -…
Longhorn Vaccines and Diagnostic
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: LONGHORN VACCINES AND DIAGNOSTIC · 2 Bethesda Metro Cente · Bethesda, MD · 20814
Is this the product you have?
- 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 Usageintended 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
- Lot codes and dates
- Lot Numbers200421A 200421B E200427A E200427B E2000505B CN200423 CN200427
- Amount recalled
- 1,936,050
Where it was sold
- Nationwide
- MD
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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