Z-2089-2018 Class II Terminated
FDA device recall Z-2089-2018 was initiated by Tosoh Bioscience Inc on Mar 5, 2018 and is designated Class II. Reason for recall: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay. The recall status is terminated (terminated Aug 31, 2020). Affected quantity: 49.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 13, 2018
- Initiation Date
- Mar 5, 2018
- Termination Date
- Aug 31, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 49
Product Description
ST-AIA PACK hsE2; Part Number: 025225 Assay, Reproductive Hormone
Reason for Recall
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Distribution Pattern
Worldwide Distribution: US (Nationwide) and countries of; Canada, Mexico, Columbia, Chile, Uruguay, Nicaragua, Argentina, Peru, Chile, Honduras. Equador, Caymen Islands, Panama, and Costa Rica.
Code Information
All Lot Codes
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2089-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026