Reported Jul 27, 2016 · Terminated
Dimension Vista¿ Homocysteine Flex Reagent Cartridge (HCYS), Device Listing No.: D017878 is an in vitro diagnostic test…
CSL Behring GmbH
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: CSL Behring GmbH · Emil-von-Behring-Str. 76 · Marburg, N/A · N/A
Is this the product you have?
- Dimension Vista¿ Homocysteine Flex Reagent Cartridge (HCYS), Device Listing No.: D017878 is an in vitro diagnostic test for the quantitative measurement of total homocysteine in human serum, heparinized plasma and EDTA plasma on the Dimension Vista System.
- Lot codes and dates
- Lot Number 15243MA Mfg Date08/31/2015
- Exp Date05/31/2016
- Lot Number 15243MB Mfg Datge08/31/2015
- Exp Date05/31/2016
- Amount recalled
- 898 units
Where it was sold
Why it was recalled
Reagent lots # 15243MA and 15243MB shows a reduced stability once opened that does not meet the Instructions For Use claim of seven (7) days. A maximum bias of -37% was observed.
This product could cause temporary or reversible health problems — stop using it.
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