Reported Jul 8, 2015 · Terminated
Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT; 100 test format, 1000 test format, and 200 test format; and…
Axis-Shield Diagnostics, Ltd.
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: Axis-Shield Diagnostics, Ltd. · The Technology Park · Dundee · N/A
Is this the product you have?
- Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT; 100 test format, 1000 test format, and 200 test format
- and Private Label(Distributed by BECKMAN COULTER, for professional use only, on the BECKMAN COULTER AU platforms (AU400, AU480
- AU680 and AU5800)) Product UsageFor in-vitro quantitative determination of total homocysteine in human plasma or serum
- Lot codes and dates
6 of 6 products · 6 lot codes
Recalled lot codes, grouped by product number Part Number Lot Number FHBC100802899574
FHRWR100802899249
FHRWR1000802899248
FHRWR200802899989
FHRWR200802899250
FHRWCN1802900104
- Amount recalled
- 52 kits + 75 kits Beckman Coulter Brand OUS
Where it was sold
Why it was recalled
Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under recovery.
This product could cause temporary or reversible health problems — stop using it.
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