i-STAT cTnI cartridge
Reported: January 8, 2020 Initiated: October 16, 2019 #Z-0761-2020
Product Description
i-STAT cTnI cartridge
Reason for Recall
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.
Details
- Recalling Firm
- Abbott Point Of Care Inc.
- Units Affected
- 3,465,875
- Distribution
- 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
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
i-STAT cTnI cartridge. Recalled by Abbott Point Of Care Inc.. Units affected: 3,465,875.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 8, 2020. Severity: Moderate. Recall number: Z-0761-2020.
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