Z-1812-2018 Class II Terminated
FDA device recall Z-1812-2018 was initiated by Tosoh Bioscience Inc on Mar 5, 2018 and is designated Class II. Reason for recall: The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results. The recall status is terminated (terminated Jun 16, 2020). Affected quantity: 2258.
Recall Details
- Product Type
- Devices
- Report Date
- May 23, 2018
- Initiation Date
- Mar 5, 2018
- Termination Date
- Jun 16, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2258
Product Description
Tosoh ST AIA-PACK HbA1c Pretreatment Solution, HbA1c Pretreatment Solution, PN 025718 The device is intended for In Vitro Diagnostic Use Only for the pretreatment of the patient samples or control set for the HbA1c assay
Reason for Recall
The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results.
Distribution Pattern
USA (nationwide) Distribution including PR and to the states of : AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, MI, MO, NC, NE, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.
Code Information
All lots.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1812-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026