ST-AIA PACK AFP; Part Number: 025252 Assay, Tumor Marker
Reported: June 13, 2018 Initiated: March 5, 2018 #Z-2065-2018
Product Description
ST-AIA PACK AFP; Part Number: 025252 Assay, Tumor Marker
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
- 3254
- 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 AFP; Part Number: 025252 Assay, Tumor Marker. Recalled by Tosoh Bioscience Inc. Units affected: 3254.
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-2065-2018.
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