FDAClass IIDecember 25, 2013

HemosIL Normal Control 1 UNASSAYED recall

HemosIL Normal Control 1 UNASSAYED Part Number: 0020003120

Why was HemosIL Normal Control 1 UNASSAYED recalled?

HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval

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?

All lots

Product
HemosIL Normal Control 1 UNASSAYED Part Number: 0020003120
Recalling firm
Instrumentation Laboratory Co.
Quantity
80319 Kits
Distribution
Nationwide Distribution
Recall date
December 25, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls