Axis-Shield Liquid Stable recall
Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT; 100 test format, 1000 test format, and 200 test format; and Private Label: (Distributed by…
Why was Axis-Shield Liquid Stable recalled?
Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under recovery.
What should I do if I have this product?
Review the official FDA enforcement record for current 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?
Part Number/Lot Number: FHBC100/802899574; FHRWR100/802899249; FHRWR1000/802899248; FHRWR200/802899989; FHRWR200/802899250; FHRWCN1/802900104
- Product
- Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT; 100 test format, 1000 test format, and 200 test format; and Private Label: (Distributed by…
- Recalling firm
- Axis-Shield Diagnostics, Ltd.
- Quantity
- 52 kits + 75 kits Beckman Coulter Brand OUS
- Distribution
- Worldwide Distribution - US Nationwide in the states of: KY, WA, CA, and PA and the country of Germany.
- Recall date
- July 8, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)