FDAClass IINovember 5, 2025

SAFE-T-FILL Micro Capillary Blood Collection recall

SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L Prepared with Dipotassium EDTA Purple, Model: 07 6011; SAFE-T-FILL Micro Capillary Blood…

Why was SAFE-T-FILL Micro Capillary Blood Collection recalled?

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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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
SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L Prepared with Dipotassium EDTA Purple, Model: 07 6011; SAFE-T-FILL Micro Capillary Blood…
Recalling firm
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
Quantity
4,272,858
Distribution
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 date
November 5, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls