Z-0761-2020 Class II Terminated
FDA device recall Z-0761-2020 was initiated by Abbott Point Of Care Inc. on October 16, 2019 and is designated Class II. 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. The recall status is terminated (terminated May 4, 2020). Affected quantity: 3,465,875.
Recall Details
- Product Type
- Devices
- Report Date
- January 8, 2020
- Initiation Date
- October 16, 2019
- Termination Date
- May 4, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,465,875
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.
Distribution Pattern
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
Code Information
List Number: 06P23-25 UDI: (01)00054749001986