FDA recall Z-0761-2020

Product

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

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

Key facts

Status

Terminated

Initiation date

2019-10-16

Report date

2020-01-08

Termination date

2020-05-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0761-2020