Recall Z-1357-2019— Abbott Laboratories

Name: FDA recall Z-1357-2019
Creator: U.S. Food and Drug Administration
Published: 2019-04-09

Class III · Terminated

Class III FDA medical device recall by Abbott Laboratories, initiated 2019-04-09, terminated 2019-12-20. It names one FDA 510(k) clearance: K063232. Product: 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.. Reason: Devices were delivered without the required dry ice..

Recalling firm: Abbott Laboratories
Classification: Class III
Status: Terminated
Initiated: 2019-04-09
Terminated: 2019-12-20
Firm location: Abbott Park, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K063232 — ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8K25-25, 8K25-01Biokit, S.A.·cleared 2007-06-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

Devices were delivered without the required dry ice.

Data sourced from openFDA. This site is unofficial and independent of the FDA.