[pending] SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L Prepared with Dipotassium EDTA Purple, Model: 0
Pending LLM rewrite. Source: FDA_DEVICE Z-0372-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- 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
- Manufacturer
- ASP Global, LLC. dba Anatomy Supply Partners, LLC.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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