Alinity i Anti-TPO Reagent Kit, List Number 09P3521
Reported: June 14, 2023 Initiated: April 24, 2023 #Z-1696-2023
Product Description
Alinity i Anti-TPO Reagent Kit, List Number 09P3521
Reason for Recall
Due to a manufacturing fill volume error, Alinity i Anti-TPO Reagent contains a marginally lower fill volume than detailed in the Kit Contents section of the Instructions for Use (IFU).
Details
- Recalling Firm
- Abbott Ireland Limited
- Units Affected
- 110 kits
- Distribution
- US Nationwide distribution in the states of CA, CO, FL, GA, IL, KY, LA, MD, MI, MN, NJ, NY, OH, RI, SC, SD, TN, TX, WA. No international distribution of affected lot.
- Location
- Sligo
Frequently Asked Questions
What product was recalled? ▼
Alinity i Anti-TPO Reagent Kit, List Number 09P3521. Recalled by Abbott Ireland Limited. Units affected: 110 kits.
Why was this product recalled? ▼
Due to a manufacturing fill volume error, Alinity i Anti-TPO Reagent contains a marginally lower fill volume than detailed in the Kit Contents section of the Instructions for Use (IFU).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 14, 2023. Severity: Low. Recall number: Z-1696-2023.
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