Recall Z-0951-2013— Diagnostica Stago, Inc.
Class II · Terminated
Class II FDA medical device recall by Diagnostica Stago, Inc., initiated 2013-01-28, terminated 2013-07-19. It names one FDA 510(k) clearance: K962675. 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 Asni¿res sur Seine (France) Coagulation Assay. Reason: Diagnostica Stago has confirmed that sometimes the delta OD measured can be changed leading to a lowered percentage result..
- Recalling firm
- Diagnostica Stago, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-01-28
- Terminated
- 2013-07-19
- Firm location
- Parsippany, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.