Abbott Laboratories: Medical Device Recall in 2020 - (Recall #: Z-1688-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

"HEMOGLOBIN A1c CALIBRATORS *** REF 4P52-01 *** 307261/R03 *** S4P5X0 *** FOR USE WITH ARCHITECT" - Product Usage: use in the calibration of the Hemoglobin A1c assay.

Product Classification:

Class II

Date Initiated: May 22, 2019

Date Posted: April 15, 2020

Recall Number: Z-1688-2020

Event ID: 85247

Reason for Recall:

Calibrator level 2 bottle may have been manufactured incorrectly for a portion of the lot. The manufacturer observed no impact to assay performance between the HbA1c concentration range of 5.33% to 6.87%. However, outside of this range, a bias of greater than 3% may be seen with patient results. The device failure that is associated with this recall can result in potentially negatively and positively biased patient test results for HbA1c. The firm is investigating the root cause.

Status: Terminated

Product Quantity: 198 Kits

Code Information:

List Number: 4P52-01 Lot Number: 54582UQ02

Distribution Pattern:

Worldwide distribution - US Nationwide distribution in the states of AR, AZ, CA, FKL GA, IA, ID, IL, IN, KS, LA, MN, MO, NC, NE, NJ, NV, NY, OH, OK, PA, SC, SD, TX, UT, VA, and WI; and countries of Austria, Germany, Italy, South Africa, and Spain.

Voluntary or Mandated:

Voluntary: Firm initiated