directCHECK whole blood control labeled with incorrect performance range
directCHECK ACT-LR whole blood quality control, level 2, is being recalled because the assayed control carries labeling with an incorrect performance range. 6,060 units affected.
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: FDA Class II recall for an incorrect printed performance range with no clinical consequence described in the source, which fits the Moderate labeling band.
Plain-English summary
The directCHECK ACT-LR whole blood quality control, level 2, model/catalog number DCGLR-2, UDI 10711234170373, is being recalled. The action covers 6,060 units in lot A6DLA001.
The stated reason is that the assayed whole blood control contains labeling with an incorrect performance range. The FDA classified the action as Class II. The source does not describe a resulting clinical consequence.
Distribution was worldwide, including nationwide in the United States across a large number of states. The controls are supplied to laboratories rather than sold to consumers.
Laboratories should identify affected stock using the catalog number, UDI and lot number above and follow the instructions issued by the manufacturer.
The recalled product
- Product
- directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2
- Manufacturer
- Accriva Diagnostics, Inc.
- Hazard
- labeling-error
- incorrect-range
- quality-control
- class-ii
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 (1)
- Lot #: A6DLA001 Unique Device Identifier: 10711234170373
Distribution
Distributed nationwide across the United States.
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