FDA-Device2013-12-25Class II
HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320
Instrumentation Laboratory Co.
Hazard
HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval
Sold states
Nationwide Distribution
Affected count
84561 kits
Manufactured in
180 Hartwell Road, N/A, Bedford, MA, United States
Products
HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0516-2014Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief