• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of March 20, 2013

  • Print
  • Share
  • E-mail
-

Product Detail

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 Asnières sur Seine (France) Coagulation Assay
Recall Number Z-0951-2013
Classification Class II
Code Info 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
Product Distributed Qty 2901 kits
Reason For Recall Diagnostica Stago has confirmed that sometimes the delta OD measured can be changed leading to a lowered percentage result.

Event Detail

Event Id 64320
Product Type Devices
Status Ongoing
Recalling Firm Diagnostica Stago, Inc.
City Parsippany
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-01-28
Initial Firm Notification of Consignee or Public E-Mail
Distribution Pattern Worldwide Distribution - USA and Canada.
-
-