Z-2952-2020Class II

PrimeStore Molecular Transport Medium (PS-MTM), Model Numbers LH-1-2, LH-1-3, LH-1-4, LH-1-5, LH-1-5CC...

Name: Z-2952-2020 PrimeStore Molecular Transport Medium (PS-MTM), Model Numbers LH-1-2, LH-1-3, LH-1-4, LH-1-5, LH-1-5CC...
Creator: Longhorn Vaccines and Diagnostic
Published: 2020-06-03
License: https://open.fda.gov/license/

Longhorn Vaccines and Diagnostics LLC / initiated 2020-06-03 / Open, Classified / root cause: labeling and UDI

FDA source

LONGHORN VACCINES AND DIAGNOSTIC began a recall of 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... on 2020-06-03. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2952-2020
Classification: Class II
Status: Open, Classified
Initiated: 2020-06-03
Posted: 2020-09-12
Recalling firm: Longhorn Vaccines and Diagnostics LLC
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.
Product code: QBD Microbial Nucleic Acid Storage And Stabilization Device
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.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: URGENT MEDICAL DEVICE CORRECTION notification letter dated 6/1/20 was distributed to the customer. Update on PrimeStore MTM (Molecular Transport Media) and guanidine thiocyanate. We are sending you this letter to notify you that PrimeStore MTM tubes may have been delivered to some users without labels. Users may not be able to identify the tubes as PrimeStore MTM tubes without these labels. If samples stored or transported in PrimeStore MTM tubes are tested on the Hologic Panther or the Hologic Fusion System 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. The Hologic Panther and the Hologic Fusion System platforms have a built-in decontamination step post-run analysis. Currently the Hologic decontamination liquid contains bleach that creates a dangerous chemical reaction producing cyanide gas when mixed with guanidine thiocyanate, one of the components of PrimeStore MTM, lysis buffers and other sample collection devices. The same reaction may occur if the PrimeStore MTM media comes into contact with bleach or other reagents containing bleach. You should evaluate procedures in your laboratory to determine if there is a risk of the PrimeStore MTM media contacting bleach or reagents containing bleach, such as during routine cleaning or decontamination following a spill. Please process the inactivated samples in PrimeStore MTM on molecular diagnostics platforms that do not use or contain bleach, and dispose of all the waste by following your Laboratorys Waste Disposal Protocols for your routine nucleic acid extraction kits (for DNA or RNA) as the guanidine in PrimeStore MTM aligns with the percentage of guanidine in other lysis buffers. Should there be any accidental spills of inactivated samples in PrimeStore MTM tubes, please
Quantity in commerce: 1,936,050
Distribution: Nationwide distribution including in the state of MD.
Product codes and lots: Lot Numbers: 200421A 200421B E200427A E200427B E2000505B CN200423 CN200427

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2952-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2952-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-09-23	2020-09-11

Product code QBD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)