Axis-Shield Liquid Stable recall
Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR1000 - Product Usage: The device can assist in the diagnosis and…
Why was Axis-Shield Liquid Stable recalled?
There is a potential performance issue as detected by an under-recovery of sample results during routine testing.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI: 05055845400183; Lot Number 902924815
- Product
- Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR1000 - Product Usage: The device can assist in the diagnosis and…
- Recalling firm
- Axis-Shield Diagnostics, Ltd.
- Quantity
- 740 total
- Distribution
- US Nationwide distribution in the states of CA, KY.
- Recall date
- January 1, 2020
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)