Z-0372-2026Class II

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

Name: Z-0372-2026 SAFE-T-FILL Micro Capillary Blood Collection, 125 L Prepared with Dipotassium EDTA Purple, Model: 07 6011...
Creator: ASP Global, LLC. dba Anatomy Supply Partners, LLC.
Published: 2025-05-05
License: https://open.fda.gov/license/

ASP Global, LLC / initiated 2025-05-05 / Open, Classified / root cause: design

FDA source

ASP Global, LLC. dba Anatomy Supply Partners, LLC. began a recall of 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... on 2025-05-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0372-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-05-05
Posted: 2025-10-27
Recalling firm: ASP Global, 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
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
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 tag: design
FDA root cause: 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. On 9/8/2025, recall notices were emailed to customers who were asked to do the following: Discontinue use of the recalled products immediately. b) Quarantine any remaining inventory to prevent further use. c) Dispose remaining inventory in accordance with local regulations or notify firm at [email protected] for return authorization and disposal assistance. d) Complete and return the enclosed Recall Response Form to confirm receipt and actions to [email protected] Distributors 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.
Quantity in commerce: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0372-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0372-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-05	2025-10-27

Product code JKA

K981973Class IISafe-T-Fill Capillary Blood Collection SystemRam Scientific / cleared 1998-09-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)