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Open, Classified

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

FDA Recall Z-0372-2026 · Posted 2025-10-27

Recalling FirmASP Global, LLC. dba Anatomy Supply Partners, LLC.
Recall StatusOpen, Classified
Product CodeJKA
Date Initiated2025-05-05
Product Quantity4,272,858

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.

Firm 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.

Root Cause

Component design/selection

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K981973SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEMRam Scientific · 1998-09-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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