Z-1419-05

PTT-LA. Lupus anticoagulant-sensitive APTT reagent. Diagnostica Stago, 6x 2mL.. Distributed in the USA by...

Name: Z-1419-05 PTT-LA. Lupus anticoagulant-sensitive APTT reagent. Diagnostica Stago, 6x 2mL.. Distributed in the USA by...
Creator: Diagnostica Stago, Inc.
Published: 2005-04-13
License: https://open.fda.gov/license/

Diagnostica Stago, Inc. / initiated 2005-04-13 / Terminated

FDA source

Diagnostica Stago, Inc. began a recall of PTT-LA. Lupus anticoagulant-sensitive APTT reagent. Diagnostica Stago, 6x 2mL.. Distributed in the USA by: Diagnostica Stago, Inc., Five Century Drive... on 2005-04-13. The reason FDA records is "Variable clotting times observed with the PTT-LA, Lupus Anticoagulant-Sensitive APTT Reagent". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1419-05
Status: Terminated
Initiated: 2005-04-13
Posted: 2005-08-30
Terminated: 2006-10-03
Recalling firm: Diagnostica Stago, Inc.
Product: PTT-LA. Lupus anticoagulant-sensitive APTT reagent. Diagnostica Stago, 6x 2mL.. Distributed in the USA by: Diagnostica Stago, Inc., Five Century Drive, Parsippany, NJ 07054.
Product code: GGW Test, Time, Partial Thromboplastin
Reason for recall: Variable clotting times observed with the PTT-LA, Lupus Anticoagulant-Sensitive APTT Reagent.
FDA root cause: Other
Action: On 4/13/2005, recall notification letters were sent to all customers and instructed them to stop using the kits and to dispose of the kits according to local regulations.
Quantity in commerce: 740 kits
Distribution: The firm distributed this product to 32 clinics/laboratories/hospitals nationwide.
Product codes and lots: Cat. No. 00599 Lot Number 041755 exp. 06/06.

Product code GGW

K921684Class IIPtt-La Test KitAmerican Bioproducts Co. / cleared 1992-06-09

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)