Diagnostica Stago STA Noplastine CI, 10 ml vial. In-Vitro… recallZ-2994-2018 · Diagnostica Stago, Inc. · initiated Jul 24, 2018
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Diagnostica Stago, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %)
FDA root cause category: Device Design
What the company is doing
Diagnostica Stago issued notification on July 24, 2018 to US Customers provided the reason for the notification, actions to be taken to mitigate the risk. Action: If you have in your laboratory, any of the lots among those listed in the appendix, we are asking you to: If it is not already done, run a Quality Control test at every change of vial. Return to your Stago affiliate, by fax or e-mail, the enclosed form completed and confirming that you have read this letter. Questions contact Stago Hotline (1-800-725-0607)
Recall details
- Recall number
- Z-2994-2018
- Status
- Terminated
- Initiated by the company
- Jul 24, 2018
- Recalling firm
- Diagnostica Stago, Inc.
- Quantity
- 5 kits
- Product code
- GJS
- FDA submissions
- K922565
- Distribution
- Nationwide
Product description
Diagnostica Stago STA Noplastine CI, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma. REF: 00666 The STA - Noplastine CI kits provide reagents for the determination of the prothrombin time (PT) in plasma with STA-R, STA Compact and STA Satellite. (In the USA this procedure has been assigned to the moderate complexity category per CLIA 1988 - CDC Analyte Code 4922; CDC Test System Codes 4677 and 4875).
Code information (models, lots, serial numbers)
Lot Number/Exp. Date/UDI 251426 2018-11-30 (01)03607450006667(11)161130(17)181130(10)251426(241)00666; 251763 2019-02-28 (01)03607450006667(11)170228(17)190228(10)251763(241)00666
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- STA® - Néoplastine® CI 10 00666Diagnostica Stago · TEST, TIME, PROTHROMBIN1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 80826).
- Z-2993-2018 · TerminatedDiagnostica Stago STA Noplastine CI Plus, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma. (REF 00667) The STA - Noplastine CI Plus kits…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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