Recall Z-1356-2019— Abbott Laboratories

Name: FDA recall Z-1356-2019
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: K121842. Product: ARCHITECT HbA1C Calibrators - Product Usage: The ARCHITECT HbA1c Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of percent hemoglobin A1c (HbA1c) in human whole blood.. 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

K121842 — ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1CAxis-Shield Diagnostics, Ltd.·cleared 2012-12-12

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 HbA1C Calibrators - Product Usage: The ARCHITECT HbA1c Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of percent hemoglobin A1c (HbA1c) in human whole blood.

Reason for recall

Devices were delivered without the required dry ice.

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