Z-0951-2013Class II

Vial Label: 1) LIATEST VWF:Ag Buffer - 5 ml Diagnostica Stago 2) LIATEST VWF:Ag Latex + 4 ml R3 Diagnostica...

Name: Z-0951-2013 Vial Label: 1) LIATEST VWF:Ag Buffer - 5 ml Diagnostica Stago 2) LIATEST VWF:Ag Latex + 4 ml R3 Diagnostica...
Creator: Diagnostica Stago, Inc.
Published: 2013-01-28
License: https://open.fda.gov/license/

Diagnostica Stago, Inc. / initiated 2013-01-28 / Terminated / root cause: software

FDA source

Diagnostica Stago, Inc. began a recall of Vial Label: 1) LIATEST VWF:Ag Buffer - 5 ml Diagnostica Stago 2) LIATEST VWF:Ag Latex + 4 ml R3 Diagnostica Stago 3) LIATEST VWF:Ag Latex Diluent 4 mL... on 2013-01-28. FDA classified it as Class II and gives the reason as "Diagnostica Stago has confirmed that sometimes the delta OD measured can be changed leading to a lowered percentage result". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0951-2013
Classification: Class II
Status: Terminated
Initiated: 2013-01-28
Posted: 2013-03-14
Terminated: 2013-07-19
Recalling firm: Diagnostica Stago, Inc.
Product: Vial Label: 1) LIATEST VWF:Ag Buffer - 5 ml Diagnostica Stago 2) LIATEST VWF:Ag Latex + 4 ml R3 Diagnostica Stago 3) LIATEST VWF:Ag Latex Diluent 4 mL Diagnostica Stago Model, catalogue, number 00518 - 58978 - 58979 Kit Label: LIATEST VWF:Ag DIAGNOSTICA STAGO S.A.S. 92600 Asnires sur Seine (France) Coagulation Assay
Product code: GJT Plasma, Coagulation Factor Deficient
Reason for recall: Diagnostica Stago has confirmed that sometimes the delta OD measured can be changed leading to a lowered percentage result.
Root cause tag: software
FDA root cause: Software design (manufacturing process)
Action: Diagnostica Stago Inc. sent e-mail notifications on 1/28/2013 to all consignees (laboratory supervisor). The written field safety notice, entitled Important Field Safety Notice, with its response form was attached. The letter identified the affected product and gave a description of the defect. Customers were asked to confirm all the results obtained in the abnormal range by either of the two methods provided. Users are to complete and return the enclosed response form as soon as possible to the Stago Hotline via fax, 973-644-9348. Questions should be directed to the Stago Hotline at 800-725-0607.
Quantity in commerce: 2901 kits
Distribution: Worldwide Distribution - USA and Canada.
Product codes and lots: Lot/Unit Numbers : Combination of All STA-R¿/ STA-R EVOLUTION¿ and lots of STA¿ - LIATEST¿ VWF: AG are involved. Lot Number Expiry date 108128 2013-03 108512 2013-04 108778 2013-07 109415 2013-10 109591 2014-01

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0951-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0951-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-20	2013-03-14

Product code GJT

K962675Class IISta - Liatest Vwf Test KitAmerican Bioproducts Co. / cleared 1996-10-25

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)