FDA Enforcement
Class III
Terminated
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 for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate.
Recall: Z-2650-2014
·
Reported September 24, 2014
Enforcement
- Recall Number
- Z-2650-2014
- Event ID
- 69070
- Classification
- Class III
- Status
- Terminated
- Product Type
- Devices
- Firm
- Diagnostica Stago, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 24, 2014
- Initiation Date
- July 18, 2014
- Classification Date
- September 16, 2014
- Termination Date
- January 16, 2015
- Address
- 5 Century Dr, N/A, Parsippany, NJ, 07054-4607, United States
Description
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 for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate.
Reason
Diagnostica Stago Inc. received some customer complaints regarding a misreading of Reagent 1 (substrate) barcode on STA analyzers.
Code Info
510(k) #K111822, Lot #112366, Part # REF 00311US
Distribution
Distributed USA (nationwide) and the country of Canada.
Quantity
514 kits