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Instrumentation Laboratory Co. recalls HemosIL Normal Control 1 UNASSAYED Part Number: 0020003120
Recalled December 25, 2013 · FDA recall Z-0514-2014 · Instrumentation Laboratory
Hazard
HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval · FDA Class II
Units
80319 Kits
Sold at
Nationwide Distribution
Description
HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval
Product
HemosIL Normal Control 1 UNASSAYED Part Number: 0020003120
Manufacturer(s)
Instrumentation Laboratory Co.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →