ST-AIA PACK C-Peptide; Part Number: 025284 Assay, Diabetes
Reported: June 13, 2018 Initiated: March 5, 2018 #Z-2074-2018
Product Description
ST-AIA PACK C-Peptide; Part Number: 025284 Assay, Diabetes
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.
Details
- Recalling Firm
- Tosoh Bioscience Inc
- Units Affected
- 1358
- Distribution
- Worldwide Distribution: US (Nationwide) and countries of; Canada, Mexico, Columbia, Chile, Uruguay, Nicaragua, Argentina, Peru, Chile, Honduras. Equador, Caymen Islands, Panama, and Costa Rica.
- Location
- Grove City, OH
Frequently Asked Questions
What product was recalled? ▼
ST-AIA PACK C-Peptide; Part Number: 025284 Assay, Diabetes. Recalled by Tosoh Bioscience Inc. Units affected: 1358.
Why was this product recalled? ▼
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 13, 2018. Severity: Moderate. Recall number: Z-2074-2018.
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