Z-0979-2007

STA Neoplastine CI Plus (10), (cat. 0667). 12 x 10 ml. in vitro diagnostic for the determination of...

Name: Z-0979-2007 STA Neoplastine CI Plus (10), (cat. 0667). 12 x 10 ml. in vitro diagnostic for the determination of...
Creator: Diagnostica Stago, Inc.
Published: 2007-03-30
License: https://open.fda.gov/license/

Diagnostica Stago, Inc. / initiated 2007-03-30 / Terminated

FDA source

Diagnostica Stago, Inc. began a recall of STA Neoplastine CI Plus (10), (cat. 0667). 12 x 10 ml. in vitro diagnostic for the determination of prothrombin time (PT) on 2007-03-30. The reason FDA records is "Based on the confirmed clotting times in the upper part of the assigned ranges of STA-Coag Control ABN control plasmas when used with STA-Neoplastine CI Plus, use of this lot may cause difficulty during the validation...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0979-2007
Status: Terminated
Initiated: 2007-03-30
Posted: 2007-07-03
Terminated: 2009-11-30
Recalling firm: Diagnostica Stago, Inc.
Product: STA Neoplastine CI Plus (10), (cat. 0667). 12 x 10 ml. in vitro diagnostic for the determination of prothrombin time (PT).
Product code: GJS Test, Time, Prothrombin
Reason for recall: Based on the confirmed clotting times in the upper part of the assigned ranges of STA-Coag Control ABN control plasmas when used with STA-Neoplastine CI Plus, use of this lot may cause difficulty during the validation of the STA-Coag Control ABN.
FDA root cause: Other
Action: Recall notification letters were sent on March 30, 2007 by first class mail. The letter advises customers that lot 061781 of STA-Neoplastine Cl Plus may cause difficulty during the vailidation process of STA-Coag Control ABN control plasmas, and asks that the lot number be discontinued.
Quantity in commerce: 170 units
Distribution: Nationwide.
Product codes and lots: Lot 061781, June 2008

Product code GJS

K922040Class IINeoplastine Ci PlusAmerican Bioproducts Co. / cleared 1992-06-23

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)