ASP Global, LLC. dba Anatomy Supply Partners, LLC.: SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L Prepared with Dipotassium EDTA Purple, Model: 07 6011; SAFE-T-FILL Micro Capillary Blo
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- ASP Global, LLC. dba Anatomy Supply Partners, LLC.
- Product
- SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L Prepared with Dipotassium EDTA Purple, Model: 07 6011; SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L Prepared with Dipotassium EDTA Self-sealing Cap, Purple, Model: 07 6013; SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L Prepared with Dipotassium EDTA Purple, Model: 07 7051; SAFE-T-FILL Micro Capillary Blood Collection, 150 ¿L Prepared with Dipotassium EDTA Purple, Model: 07 7052; SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L Prepared with Dipotassium EDTA Purple, Model: 07 7053; SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L Prepared with Dipotassium EDTA Purple, Model: 07 7056; SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L Prepared with Dipotassium EDTA Flat Bottom Microtube, Purple, Model: 07 7058 SAFE-T-FILL¿ End-to-End Capillary Tubes, 30 ¿L; Plastic, Prepared with EDTA Dipotassium Model: 06 0910
- Reason / hazard
- 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- 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.
- Recall initiated
- 2025-05-05
- Code info
- Model/UDI-DI/Lots: 07 6011/10643351000014/23H4110, 23I4017, 23I4051, 23J4031, 23K4058, 23K4059, 23L4082, 24A4103, 24B4186, 24B4187, 24D4015, 24E4138, 24E4139, 24H4121, 24I4317, 24I4328, 24J4041, 24J4137, 24J4138, 24J4233, 24J4316, 24J4348; 07 6013/10643351000021/23H4111, 23I4018, 24B4188, 24H4125, 25B4099; 07 7051/10643351000038/23H4157, 23I4020, 23I4374, 23J4033, 23K4060, 23L4083, 24A4104, 24B4190, 24D4016, 24E4140, 24F4053, 24I4321, 24J4043, 24J4139, 24J4237, 24L4001, 25B4107; 07 7052/10643351000045/23H4113, 23I4021, 23J4034, 24A4105, 24D4017, 24F4052, 24H4126, 24I4323, 24J4042, 24J4140, 24J4338, 24J4355, 25B4108; 07 7053/10643351000052/23I4022, 23J4035, 23L4084, 24D4018, 24E4132, 24F4192, 25B4106; 07 7056/10643351000069/24A4106, 24B4191, 24B4192, 24E4133, 24I4315, 24J4136, 24J4347; 07 7058/10643351000076/23G4430, 23G4168. Manufactured between July 31, 2023 and February 28, 2025.
- Product quantity
- 4,272,858
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Austell
- State
- GA
- Country
- United States
- Event id
- 97551
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