# FDA recall Z-1688-2020

> **Abbott Laboratories** · Class II · device recall initiated 2019-05-22.

## Product

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

## 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.

## Distribution

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.

## Key facts

- **Recall number:** Z-1688-2020
- **Recalling firm:** Abbott Laboratories
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-05-22
- **Report date:** 2020-04-15
- **Termination date:** 2021-01-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irving, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1688-2020

## Citation

> AI Analytics. FDA recall Z-1688-2020. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/Z-1688-2020. Source: US FDA. Licensed CC0.

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