Avid Medical QA Pack Recall Due to Expired Swab Stick Component
Avid Medical is recalling 330 QA Packs because the included swab stick expires before the kit's expiration date.
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: The recall is classified as FDA Class II, but the hazard is a labeling/expiration discrepancy without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Avid Medical, Inc. is recalling 330 units of the AVID Medical QA Pack AV10654-10. The recall is being conducted because the swab stick collection device provided in the convenience kit expires prior to the kit expiration date.
The affected products were distributed to seventeen sites located in 13 states: Florida, Indiana, Kansas, Kentucky, Massachusetts, Oklahoma, North Carolina, Nebraska, New York, Ohio, Pennsylvania, Virginia, and Texas. The specific lot information includes Avid Medical Kit Lot 1235229 (expiration date 2017-08-01) and Swab Stick lots 5M03A (expiration date 2017-06-03) and 6A21A (expiration date 2017-07-21).
Consumers and healthcare facilities should stop using the affected QA Packs and contact Avid Medical, Inc. for further instructions or a replacement.
The recalled product
- Product
- AVID Medical QA Pack AV10654-10
- Manufacturer
- Avid Medical, Inc.
- Category
- Medical Device — Diagnostic Kits
- Affected units
- 330
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)
- Avid Medical Kit Lot 1235229 (expiration date 2017-08-01)
Distribution
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