St-aia Pack CA 19-9 recall
ST-AIA PACK CA 19-9; Part Number: 025271 Assay, Tumor Marker
Why was St-aia Pack CA 19-9 recalled?
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All Lot Codes
- Product
- ST-AIA PACK CA 19-9; Part Number: 025271 Assay, Tumor Marker
- Recalling firm
- Tosoh Bioscience Inc
- Quantity
- 4824
- 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.
- Recall date
- June 13, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)