Stago IVD recall
Stago IVD, Liquid Anti-Xa, NDC 3607450003116. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite Analyzers…
Why was Stago IVD recalled?
Diagnostica Stago Inc. received some customer complaints regarding a misreading of Reagent 1 (substrate) barcode on STA analyzers.
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?
510(k) #K111822, Lot #112366, Part # REF 00311US
- Product
- Stago IVD, Liquid Anti-Xa, NDC 3607450003116. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite Analyzers…
- Recalling firm
- Diagnostica Stago, Inc.
- Quantity
- 514 kits
- Distribution
- Distributed USA (nationwide) and the country of Canada.
- Recall date
- September 24, 2014
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)