STA - Deficient VIII recall: Contamination
STA - Deficient VIII, Product Code: 00725. STA - Deficient VIII is an immuno-depleted human plasma intended for use in tests for the determination of…
Why was STA - Deficient VIII recalled?
A risk of sample-to-sample cross-contamination of Emicizumab for factor VIII assays on Stago instruments, clotting times will be shortened that may cause factor VIII levels reported to be falsely increased
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 lots This cleaning sequence has been implemented in the following available software versions. Customers not possessing these software levels will be upgraded by Stago Field Support personnel: STA-R¿ Max (all serial numbers): Software version 4.05.04 or higher, and Methodology Update (MU) to enhance database version MS215. STA-R¿ Evolution (serial numbers higher than 8012756): Software version 3.04.09 or higher STA¿ Compact Max (all serial numbers): Software version 110.05 or higher.
- Product
- STA - Deficient VIII, Product Code: 00725. STA - Deficient VIII is an immuno-depleted human plasma intended for use in tests for the determination of…
- Recalling firm
- Diagnostica Stago, Inc.
- Quantity
- 3,225 units
- Distribution
- Nationwide
- Recall date
- April 22, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)