FDA recall Z-1359-2019

Product

ARCHITECT STAT High Sensitive Troponin-I Controls - Product Usage: The ARCHITECT STAT High Sensitive Troponin-I Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of cardiac troponin I (cTnI) in human serum and plasma with the ARCHITECT STAT High Sensitive Troponin-I reagent kit.

Reason for recall

Devices were delivered without the required dry ice.

Distribution

Distribution to Latvia.

Key facts

Status

Terminated

Initiation date

2019-04-09

Report date

2019-05-22

Termination date

2019-12-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Abbott Park, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1359-2019