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

FDA device recall Z-0372-2026 · posted 2025-10-27 · Open, Classified

Recall details

Recalling firm

ASP Global, LLC. dba Anatomy Supply Partners, LLC.

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.

Action taken

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 FieldActions@aspglobal.com for return authorization and disposal assistance. d) Complete and return the enclosed Recall Response Form to confirm receipt and actions to FieldActions@aspglobal.com 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.

Root cause

Component design/selection

Status

Open, Classified

Product code

JKA

Quantity affected

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

Date initiated

2025-05-05

Date posted

2025-10-27

Location

Austell, GA

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