Abbott Laboratories: Medical Device Recall in 2019 - (Recall #: Z-1359-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class III

Date Initiated: April 9, 2019

Date Posted: May 22, 2019

Recall Number: Z-1359-2019

Event ID: 82590

Reason for Recall:

Devices were delivered without the required dry ice.

Status: Terminated

Product Quantity: 2 units

Code Information:

LN 3P25-11; Lot 94347UIOO

Distribution Pattern:

Distribution to Latvia.

Voluntary or Mandated:

Voluntary: Firm initiated