Z-2994-2018Class II

Diagnostica Stago STA Noplastine CI, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin...

Name: Z-2994-2018 Diagnostica Stago STA Noplastine CI, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin...
Creator: Diagnostica Stago, Inc.
Published: 2018-07-24
License: https://open.fda.gov/license/

Diagnostica Stago, Inc. / initiated 2018-07-24 / Terminated / root cause: design

FDA source

Diagnostica Stago, Inc. began a recall of 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... on 2018-07-24. FDA classified it as Class II and gives the reason as "QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2994-2018
Classification: Class II
Status: Terminated
Initiated: 2018-07-24
Posted: 2018-09-07
Terminated: 2020-05-18
Recalling firm: Diagnostica Stago, Inc.
Product: 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).
Product code: GJS Test, Time, Prothrombin
Reason for recall: QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %)
Root cause tag: design
FDA root cause: Device Design
Action: 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)
Quantity in commerce: 5 kits
Distribution: Nationwide
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2994-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2993-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-19	2018-09-07
Z-2994-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-19	2018-09-07

Product code GJS

K922565Class IINeoplastine(r) Ci KitAmerican Bioproducts Co. / cleared 1992-12-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)