FDA Device recall Z-2650-2014
Stago IVD, Liquid Anti-Xa, NDC 3607450003116
- FDA Device
- Class III
- terminated
- Published 2014-09-24
On 2014-09-24 the FDA classified a Class III recall of Stago IVD, Liquid Anti-Xa, NDC 3607450003116 by Diagnostica Stago, citing diagnostica Stago Inc. received some customer complaints regarding a misreading of Reagent 1 (substrate) barcode on STA analyzers.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2650-2014 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2014-07-18 |
| Published | 2014-09-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Diagnostica Stago |
| Distribution | US |
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 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.
Identifiers
| code_info | 510(k) #K111822, Lot #112366, Part # REF 00311US |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2650-2014%22
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