PrimeStore Molecular Transport Medium — Class II medical device recall Z-2952-2020
Ongoing recall by LONGHORN VACCINES AND DIAGNOSTIC, reported 2020-09-23, distributed nationwide. The tubes may have been delivered to some users without labels. Users may not be able to identify the tubes wi
| Recall number | Z-2952-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | LONGHORN VACCINES AND DIAGNOSTIC, Bethesda, MD, United States |
| Recall initiated | 2020-06-03 |
| Classified | 2020-09-11 |
| Reported by FDA | 2020-09-23 |
| Distributed | Nationwide (US) |
| Quantity | 1,936,050 |
| Reason classes | labeling |
| Lot numbers | 200421A, 200421B, CN200423, CN200427, E2000505B, E200427A, E200427B |
| Model numbers | LH-1-15CC, LH-1-2, LH-1-3, LH-1-4, LH-1-5, LH-1-5CC |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2952-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.