CLASS II Device recall · Reported 20 Mar 2013 · FDA Enforcement Report
Vial Label: Liatest Vwf:Ag Buffer recalled by Diagnostica Stago
Diagnostica Stago is recalling Vial Label: Liatest Vwf:Ag Buffer - Diagnostica Stago Liatest Vwf:Ag Latex + R3. The recall was initiated on 28 Jan 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0951-2013
- FDA event ID
- 64320
- Recalling firm
- Diagnostica Stago, Parsippany, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Jan 2013
- FDA classified
- 14 Mar 2013
- Reported
- 20 Mar 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 28 Jan 2013 | Recall initiated by company | |
| 14 Mar 2013 | Classified by FDA | +45 days |
| 20 Mar 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Diagnostica Stago has confirmed that sometimes the delta OD measured can be changed leading to a lowered percentage result.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Worldwide Distribution - USA and Canada.
Questions about this recall
Why was it recalled?
Diagnostica Stago has confirmed that sometimes the delta OD measured can be changed leading to a lowered percentage result.
Which lots are affected?
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
Where was it sold?
Worldwide Distribution - USA and Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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