Abbott Laboratories: Medical Device Recall in 2019 - (Recall #: Z-1357-2019)

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 Intact PTH Controls - Product Usage: The ARCHITECT Intact PTH Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of Intact PTH in human serum and plasma.

Product Classification:

Class III

Date Initiated: April 9, 2019

Date Posted: May 22, 2019

Recall Number: Z-1357-2019

Event ID: 82590

Reason for Recall:

Devices were delivered without the required dry ice.

Status: Terminated

Product Quantity: 1 unit

Code Information:

LN 8K25-12; Lot 01018I000

Distribution Pattern:

Distribution to Latvia.

Voluntary or Mandated:

Voluntary: Firm initiated