{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "215914", "product_res_number": "Z-0372-2026", "event_date_initiated": "2025-05-05", "event_date_posted": "2025-10-27", "recall_status": "Open, Classified", "res_event_number": "97551", "product_code": "JKA", "k_numbers": [ "K981973" ], "product_description": "SAFE-T-FILL Micro Capillary Blood Collection, 125 L Prepared with Dipotassium EDTA Purple, Model: 07 6011;\nSAFE-T-FILL Micro Capillary Blood Collection, 125 L Prepared with Dipotassium EDTA Self-sealing Cap, Purple, Model: 07 6013;\nSAFE-T-FILL Micro Capillary Blood Collection, 200 L Prepared with Dipotassium EDTA Purple, Model: 07 7051;\nSAFE-T-FILL Micro Capillary Blood Collection, 150 L Prepared with Dipotassium EDTA Purple, Model: 07 7052;\nSAFE-T-FILL Micro Capillary Blood Collection, 300 L Prepared with Dipotassium EDTA Purple, Model: 07 7053;\nSAFE-T-FILL Micro Capillary Blood Collection, 200 L Prepared with Dipotassium EDTA Purple, Model: 07 7056;\nSAFE-T-FILL Micro Capillary Blood Collection, 200 L Prepared with Dipotassium EDTA Flat Bottom Microtube, Purple, Model: 07 7058\nSAFE-T-FILL End-to-End Capillary Tubes, 30 L; Plastic, Prepared with EDTA Dipotassium\nModel: 06 0910", "code_info": "Model/UDI-DI/Lots:\n\t\n07 6011/10643351000014/23H4110, 23I4017, 23I4051, 23J4031, 23K4058, 23K4059, 23L4082, 24A4103, 24B4186, 24B4187, 24D4015, 24E4138, 24E4139, 24H4121, 24I4317, 24I4328, 24J4041, 24J4137, 24J4138, 24J4233, 24J4316, 24J4348;\t\n07 6013/10643351000021/23H4111, 23I4018, 24B4188, 24H4125, 25B4099;\t\n07 7051/10643351000038/23H4157, 23I4020, 23I4374, 23J4033, 23K4060, 23L4083, 24A4104, 24B4190, 24D4016, 24E4140, 24F4053, 24I4321, 24J4043, 24J4139, 24J4237, 24L4001, 25B4107;\t\n07 7052/10643351000045/23H4113, 23I4021, 23J4034, 24A4105, 24D4017, 24F4052, 24H4126, 24I4323, 24J4042, 24J4140, 24J4338, 24J4355, 25B4108;\n07 7053/10643351000052/23I4022, 23J4035, 23L4084, 24D4018, 24E4132, 24F4192, 25B4106;\t\n07 7056/10643351000069/24A4106, 24B4191, 24B4192, 24E4133, 24I4315, 24J4136, 24J4347;\n07 7058/10643351000076/23G4430, 23G4168.\n\nManufactured between July 31, 2023 and February 28, 2025.", "firm_fei_number": "3004824601", "recalling_firm": "ASP Global, LLC. dba Anatomy Supply Partners, LLC.", "address_1": "7800 Third Flag Pkwy", "city": "Austell", "state": "GA", "postal_code": "30168-7657", "additional_info_contact": "Tracy Weldon\n404-696-6999", "reason_for_recall": "All RAM SAFE-T-FILL Micro Capillary Blood Collection tubes manufactured between July 31, 2023 to February 28, 2025 cause false positive results when used with Magellan Diagnostics LeadCare Testing Systems. False positive lead results may cause delayed results and additional unnecessary testing.", "root_cause_description": "Component design/selection", "action": "Starting on 5//5/2025 customers were informed that there had been reports of falsely elevated blood lead levels associated with the use of affected micro capillary tubes for lead testing when used with Magellan LeadCare Testing Systems.\n\n On 9/8/2025, recall notices were emailed to customers who were asked to do the following:\nDiscontinue use of the recalled products immediately.\nb) Quarantine any remaining inventory to prevent further use.\nc) Dispose remaining inventory in accordance with local regulations or notify firm at\nFieldActions@aspglobal.com for return authorization and disposal assistance.\nd) Complete and return the enclosed Recall Response Form to confirm receipt and actions\nto FieldActions@aspglobal.com\n\nDistributors are asked to notify their customers of the recall or to forward their customer information to the recalling firm so they might notify these customers.", "product_quantity": "4,272,858", "distribution_pattern": "Worldwide - US Nationwide distribution including in the states of AK, AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, PA, SC, SD, TN, TX, UT, VA, WA, WI and the country of CA.", "openfda": { "k_number": [ "K021941", "K900856", "K213718", "K922445", "K983490", "K023075", "K223810", "K222141", "K945777", "K013971", "K933401", "K201237", "K201009", "K063852", "K791303", "K960858", "K971111", "K953994", "K222299", "K802211", "K945353", "K030076", "K202325", "K244047", "K830472", "K200027", "K230408", "K160657", "K232781", "K884111", "K191832", "K890109", "K011699", "K120490", "K220900", "K810664", "K921520", "K926253", "K181895", "K231237", "K954592", "K902442", "K060364", "K152924", "K971220", "K901449", "K233979", "K081229", "K252378", "K213146", "K243207", "K193569", "K792587", "K993787", "K991088", "K162233", "K823836", 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