FDAFDA · Food and drugs·Recall number Z-0761-2020
i-STAT cTnI cartridge
Published January 8, 2020 · Recall initiated: October 16, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
i-STAT¿ cTnI blue cartridges may generate a higher than expected number of quality check codes. The observed rate of quality check codes could be in the 3 to 5% range.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Abbott Point Of Care Inc.
- Distributor
- US: AK AL AZ CA CT DC FL GA HI IL IN KS KY MD MI MS NC NE NH NM NV NY OH OK OR PA SC SD TN TX VA WA WV WY
- Lot
- List Number: 06P23-25 UDI: (01)00054749001986
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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