Z-1688-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 15, 2020
- Initiation Date
- May 22, 2019
- Termination Date
- January 22, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 198 Kits
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.
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 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.
Code Information
List Number: 4P52-01 Lot Number: 54582UQ02