FDA-Device2018-03-14Class II
Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400
Instrumentation Laboratory Co.
Hazard
Instrumentation Laboratory Co. received customer reports of performance issues with some vials of Lot Nos. N1166235 and N0177760, including increased imprecision, out of range quality controls and prolonged sample results.
Sold states
Worldwide Distribution - US Nationwide
Affected count
14,894 kits
Manufactured in
180 Hartwell Rd, N/A, Bedford, MA, United States
Products
Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0895-2018Don't want to check this manually?
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