Capillary blood tubes recalled for causing false positive lead test results
ASP Global is recalling 4,272,858 SAFE-T-FILL capillary blood collection tubes because tubes made between July 2023 and February 2025 cause false positive results on LeadCare testing systems.
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: Scored 3 under the risk-of-harm criterion: false positive lead results can trigger unnecessary follow-up and delay correct results, and no injuries are reported.
Plain-English summary
SAFE-T-FILL Micro Capillary Blood Collection tubes, 125 microlitre, prepared with dipotassium EDTA, in purple and self-sealing cap variants (models 07 6011, 07 6013 and others), are being recalled.
All RAM SAFE-T-FILL Micro Capillary Blood Collection tubes manufactured between 31 July 2023 and 28 February 2025 cause false positive results when used with Magellan Diagnostics LeadCare Testing Systems. The firm states false positive lead results may cause delayed results and additional unnecessary testing.
The recall covers 4,272,858 units, across lots including 23H4110, 23I4017, 23I4051, 23J4031, 23K4058, 23K4059 and 23L4082. Distribution was worldwide, including nationwide in the United States. The FDA has classified the action as Class II.
Laboratories should identify affected lots and follow the firm's instructions.
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
- Affected units
- 4,272,858
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
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