Analyzing system consists of a small and portable recall
Analyzing system consists of a small and portable analyzer and plastic microcuvettes. The microcuvette contains reagents deposited on its inner walls.…
Why was Analyzing system consists of a small and portable recalled?
Incorrect version of Quick Reference Guide (QRG) was delivered with products in shipment made from April1 st 2011 and onwards. In addition, a warranty statement was missing in the analyzer package.
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?
See serial numbers of affected devices in attachment profided by firm.
- Product
- Analyzing system consists of a small and portable analyzer and plastic microcuvettes. The microcuvette contains reagents deposited on its inner walls.…
- Recalling firm
- HemoCue AB
- Quantity
- 48 affected analyzers
- Distribution
- Distributed in the states of FL, MA, CA, OR, NY, NC, MO, ID, IN, KY, PA, TX, OK, IL, GA, KS, and UT.
- Recall date
- January 9, 2013
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)