PlainRecalls
FDA Devices Moderate Class II Terminated

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 Asni¿res sur Seine (France) Coagulation Assay

Reported: March 20, 2013 Initiated: January 28, 2013 #Z-0951-2013

Product Description

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 Asni¿res sur Seine (France) Coagulation Assay

Reason for Recall

Diagnostica Stago has confirmed that sometimes the delta OD measured can be changed leading to a lowered percentage result.

Details

Recalling Firm
Diagnostica Stago, Inc.
Units Affected
2901 kits
Distribution
Worldwide Distribution - USA and Canada.
Location
Parsippany, NJ

Frequently Asked Questions

What product was recalled?
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 Asni¿res sur Seine (France) Coagulation Assay. Recalled by Diagnostica Stago, Inc.. Units affected: 2901 kits.
Why was this product recalled?
Diagnostica Stago has confirmed that sometimes the delta OD measured can be changed leading to a lowered percentage result.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 20, 2013. Severity: Moderate. Recall number: Z-0951-2013.