Class II — LONGHORN VACCINES AND DIAGNOSTIC
| Recalling firm | Longhorn Vaccines and Diagnostics LLC |
|---|---|
| Registered facility | Longhorn Vaccines and Diagnostics LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| 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. |
| Quantity | 1,936,050 |
| Distribution | Nationwide distribution including in the state of MD. |
| Initiated | 2020-06-03 |
| Classified | 2020-09-11 |
| Recall number | Z-2952-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — LONGHORN VACCINES AND DIAGNOSTIC (Z-2952-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86189/
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