Untreated hematocrit tubes recalled over an inadequate quality system
ASP Global is recalling 209,000 SAFE-T-FILL microhematocrit capillary tubes, 50 microlitres untreated, over an inadequate quality system with unvalidated processes.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, untreated with blue markings, model 06 0508, from ASP Global doing business as Anatomy Supply Partners, are being recalled. The product is a clear plastic capillary blood collection tube.
The recall follows products manufactured under an inadequate quality system, including unvalidated manufacturing processes.
The recall covers 209,000 units carrying UDI-DI 10643351000380, across all lots produced from 1 August 2020 through 28 February. 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; Untreated, Blue Markings Model/Catalog Number: 06 0508 Product Description: A clear, plastic capillary blood collection tube
- Affected units
- 209,000
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 (13)
- 21L4388
- 22G4487
- 23C4341
- 23F4164
- 23G4172
- 23G4210
- 24I4053
- 24I4327
- 24I4330
- 24I4331
- 24I4409
- 24J4141
- 24J4350
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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