Reported Jan 1, 2020 · Ongoing
Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHBC100 - Product Usage: The device can assist…
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. · 17 Luna Place · Dundee · N/A
Is this the product you have?
- Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT
- Part Number FHBC100 - Product UsageThe device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. The device is intended for Professional use only
- Lot codes and dates
- UDI
05055845400282Lot Numbers 902924530902925703
- UDI
- Amount recalled
- 740 total
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
There is a potential performance issue as detected by an under-recovery of sample results during routine testing.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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