Microhematocrit capillary tubes recalled over an inadequate quality system
ASP Global is recalling 2,000 SAFE-T-FILL microhematocrit capillary tubes, 50 microlitres, over an inadequate quality system with unvalidated processes.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record cites a quality system and process validation finding rather than an identified defect or reported harm.
Plain-English summary
SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 microlitres, plastic and ammonium heparinized with red marking, model 06 0507, from ASP Global doing business as Anatomy Supply Partners, are being recalled. The product is a clear plastic capillary blood collection tube coated with heparin.
The recall follows products manufactured under an inadequate quality system, including unvalidated manufacturing processes.
The recall covers 2,000 units carrying UDI-DI 10643351000397, across all lots produced from a stated start date. The product was distributed nationwide in the United States and in Canada. The FDA has classified the action as Class II.
The enforcement record cites the quality system finding without describing a device defect or health consequence, and reports no injuries. Laboratories holding affected stock should follow the firm's instructions.
The recalled product
- Product
- SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 ¿L; Plastic, Ammonium Heparinized, Red Marking Model/Catalog Number: 06 0507 Product Description: A clear, plastic capillary blood collection tube coated with Heparin
- Affected units
- 2,000
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 24 recalled by ASP Global, LLC. dba Anatomy Supply Partners, LLC. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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