{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "182998", "product_res_number": "Z-2952-2020", "event_date_initiated": "2020-06-03", "event_date_created": "2020-09-12", "recall_status": "Open, Classified", "res_event_number": "86189", "product_code": "QBD", "product_description": "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_info": "Lot Numbers: 200421A 200421B E200427A E200427B E2000505B CN200423 CN200427", "firm_fei_number": "3011818318", "recalling_firm": "LONGHORN VACCINES AND DIAGNOSTIC", "address_1": "2 Bethesda Metro Cente 2 Bethesda Metro Cente", "city": "Bethesda", "state": "MD", "postal_code": "20814", "additional_info_contact": "Jeff Fischer\n301-233-1551", "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_description": "Error in labeling", "action": "URGENT MEDICAL DEVICE CORRECTION notification letter dated 6/1/20 was distributed to the customer.\n\nUpdate on PrimeStore MTM (Molecular Transport Media) and guanidine\nthiocyanate.\n\nWe are sending you this letter to notify you that PrimeStore MTM tubes may have been delivered to\nsome users without labels. Users may not be able to identify the tubes as PrimeStore MTM tubes\nwithout these labels. If samples stored or transported in PrimeStore MTM tubes are tested on the\nHologic Panther or the Hologic Fusion System or come into contact with bleach they can produce\ncyanide gas. The solution in these tubes contains guanidine thiocynate and may put laboratory\npersonnel at risk of exposure to cyanide gas when it comes into contact with bleach or reagents\ncontaining bleach.\nThe Hologic Panther and the Hologic Fusion System platforms have a built-in decontamination step\npost-run analysis. Currently the Hologic decontamination liquid contains bleach that creates a\ndangerous chemical reaction producing cyanide gas when mixed with guanidine thiocyanate, one\nof the components of PrimeStore MTM, lysis buffers and other sample collection devices. The\nsame reaction may occur if the PrimeStore MTM media comes into contact with bleach or other\nreagents containing bleach. You should evaluate procedures in your laboratory to determine if\nthere is a risk of the PrimeStore MTM media contacting bleach or reagents containing bleach, such\nas during routine cleaning or decontamination following a spill.\n\nPlease process the inactivated samples in PrimeStore MTM on molecular diagnostics platforms that\ndo not use or contain bleach, and dispose of all the waste by following your Laboratorys Waste\nDisposal Protocols for your routine nucleic acid extraction kits (for DNA or RNA) as the guanidine in\nPrimeStore MTM aligns with the percentage of guanidine in other lysis buffers.\nShould there be any accidental spills of inactivated samples in PrimeStore MTM tubes, please", "product_quantity": "1,936,050", "distribution_pattern": "Nationwide distribution including in the state of MD.", "openfda": { "k_number": [ "K210440", "K201849", "K221664", "K222771", "K211675", "K221547", "K240797", "K231013", "DEN170029", "K202641", "K233324", "K223497", "K242820", "K212113", "K221802", "K212878", "K220059" ], "registration_number": [ "3016635427", "1216735", "3031001098", "3013373509", "3013740892", "3009613136", "3016764932", "3016741564", "3011818318", "3027266036", "3002444944", "3025663244", "1616487", "2436875", "3012758946", "3013046485", "3010407203", "3017101757", "3004530258", "3003272500", "3017830316", "3016838963", "3017014794" ], "fei_number": [ "3016635427", "1216735", "3031001098", "1000521444", "3013373509", "3013740892", "3009613136", "3016764932", "3016741564", "3011818318", "3027266036", "3002444944", "3025663244", "1616487", "3012758946", "3013046485", "3010407203", "3017101757", "3004530258", "3003272500", "3017830316", "3016838963", "3017014794" ], "device_name": "Microbial Nucleic Acid Storage And Stabilization Device", "medical_specialty_description": "Microbiology", "regulation_number": "866.2950", "device_class": "2" } } ] }