Clearest Strep-A cassette test recalled because it lacks FDA clearance
Altruan GmbH is recalling the Clearest Strep-A Cassette Test, used to detect group A streptococci in throat swab samples, because the product is not cleared by the FDA.
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: Rubric level 2 covers voluntary precautionary recalls: the recall is for a missing regulatory clearance and the source describes no defect, malfunction or hazard in the product.
Plain-English summary
Altruan GmbH is recalling the Clearest Strep-A Cassette Test, a test to determine the presence of group A streptococci in throat swab samples. About 188 units were distributed nationwide in the United States. The FDA has classified this recall as Class II.
The product is not cleared by the FDA. The source record does not describe a defect, malfunction or hazard in the test itself.
Affected product is model SP-C310343-10, lot code 01242573. The product carries no UDI.
Facilities can identify affected tests by the model and lot code above, and may contact Altruan GmbH for further information.
The recalled product
- Product
- Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci (Strep A) in throat swab samples.
- Manufacturer
- Altruan GmbH
- Category
- Medical Device — Diagnostic test
- Affected units
- 188
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 (3)
- Model No. SP-C310343-10
- No UDI
- Lot Code: 01242573.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Altruan GmbH 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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