FDA-Device2012-06-27Class III
Manual Method 1: 480 Test Kit (PreCoat), Catalog/Model # 490529
Tripath Imaging, Inc.
Hazard
The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. This event resulted in an increase in complaints of leaking syringing pipettes
Sold states
Worldwide Distribution.
Affected count
46,112,784 for all products in Recall Event
Manufactured in
780 Plantation Dr, N/A, Burlington, NC, United States
Products
Manual Method 1: 480 Test Kit (PreCoat), Catalog/Model # 490529
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1814-2012Don't want to check this manually?
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