Class 2 Device Recall PrimeStore Molecular Transport Medium (PSMTM)

• Date Initiated by Firm: June 03, 2020
• Create Date: September 12, 2020
• Recall Status: Open, Classified
• Recall Number: Z-2952-2020
• Recall Event ID: 86189
• Product Classification: Microbial nucleic acid storage and stabilization device - Product Code QBD
• 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.
• Code Information: Lot Numbers: 200421A 200421B E200427A E200427B E2000505B CN200423 CN200427
• FEI Number: 3011818318
• Recalling Firm/ Manufacturer: LONGHORN VACCINES AND DIAGNOSTIC; 2 Bethesda Metro Cente; Bethesda MD 20814
• For Additional Information Contact: Jeff Fischer; 301-233-1551
• Manufacturer 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.
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.