Abbott Alinity i Anti-TPO Reagent Kit Recalled for Fill Volume Error
Abbott is recalling Alinity i Anti-TPO Reagent Kit (Lot 46009FN00) due to a manufacturing error resulting in marginally lower fill volume than specified in the Instructions for Use. Approximately 110 kits were distributed nationwide across 17 US states.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: FDA Class III recall with no reported illnesses or injuries. The marginal fill volume discrepancy represents a documentation and compliance issue rather than an imminent patient safety hazard.
Plain-English summary
Abbott Ireland Limited is recalling the Alinity i Anti-TPO Reagent Kit (List Number 09P3521, Lot 46009FN00) due to a manufacturing error affecting fill volume. The recalled kits contain a marginally lower fill volume than specified in the Instructions for Use documentation.
The affected kits were distributed nationwide across 17 US states: California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Maryland, Michigan, Minnesota, New Jersey, New York, Ohio, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, and Washington. Approximately 110 kits with an expiration date of July 20, 2024 were affected. No international distribution of this lot occurred.
The recalled product
- Product
- Alinity i Anti-TPO Reagent Kit, List Number 09P3521
- Manufacturer
- Abbott Ireland Limited
- Affected units
- 110
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 (4)
- UDI Number: (01)00380740153892(17)240720(10)46009FN00
- List Number: 09P3521
- Lot Number: 46009FN00
- Expiration Date: 07/20/2024
Distribution
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