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Recall

Class II — Diagnostica Stago, Inc.

Recalling firmDiagnostica Stago, Inc.
Registered facilityDIAGNOSTICA STAGO, INC. (the firm's only registered facility)
ClassificationClass II
StatusTerminated
ReasonDiagnostica Stago has confirmed that sometimes the delta OD measured can be changed leading to a lowered percentage result.
ProductVial 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
Quantity2901 kits
DistributionWorldwide Distribution - USA and Canada.
Initiated2013-01-28
Classified2013-03-14
Terminated2013-07-19
Recall numberZ-0951-2013
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Diagnostica Stago, Inc. (Z-0951-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/64320/

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