FDAFDA · Food and drugs·Recall number Z-2087-2018
ST-AIA PACK Prolactin; Part Number: 025255 Assay, Reproductive Hormone
Published June 13, 2018 · Recall initiated: March 5, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Tosoh Bioscience Inc
- Distributor
- Worldwide Distribution: US (Nationwide) and countries of; Canada, Mexico, Columbia, Chile, Uruguay, Nicaragua, Argentina, Peru, Chile, Honduras. Equador, Caymen Islands, Panama, and Costa Rica.
- Lot
- All Lot Codes
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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