Z-1068-2018Class II

STA - Neoplastine Cl (ref. 00605)

Name: Z-1068-2018 STA - Neoplastine Cl (ref. 00605)
Creator: Diagnostica Stago, Inc.
Published: 2017-10-25
License: https://open.fda.gov/license/

Diagnostica Stago, Inc. / initiated 2017-10-25 / Terminated / root cause: design

FDA source

Diagnostica Stago, Inc. began a recall of STA - Neoplastine Cl (ref. 00605) Product Usage: Manual or automated determination of the prothrombin time (PT) on 2017-10-25. FDA classified it as Class II and gives the reason as "Confirmed defect of homogeneity where some reagent vials will give 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-1068-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-25
Posted: 2018-03-15
Terminated: 2020-05-12
Recalling firm: Diagnostica Stago, Inc.
Product: STA - Neoplastine Cl (ref. 00605) Product Usage: Manual or automated determination of the prothrombin time (PT).
Product code: GJS Test, Time, Prothrombin
Reason for recall: Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%).
Root cause tag: design
FDA root cause: Device Design
Action: Stago sent an Urgent Field Safety Notice letter dated October 25, 2017 to their customers. The letter identified the affected product, problem and actions to be taken: Customers were instructed to: If it is not already done, run a Quality Control test at every change of vial (if you have affected lots of product). Return to company, by fax or email, an acknowledgement form confirming that the recall letter was read by the receiving company. For questions contact the Stago Hotline (1-800-725-0607).
Distribution: Nationally
Product codes and lots: Lot 251064 (Exp: 09-2018) Lot 251725 (Exp: 02-2019)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1068-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1066-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-15
Z-1067-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-15
Z-1068-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-15
Z-1069-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-15

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)