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Recall Observatory FDA recall evidence

Device product

Manual Method 1: 480 Test Kit (PreCoat), Catalog/Model # 490529

Z-1814-2012

March 22, 2012

Class III

Product summary

Firm
Tripath Imaging, Inc.
Event
Event 61737
Status
Terminated
Classification
Class III
Quantity
46,112,784 for all products in Recall Event
Official record key
device-enforcement:Z-1814-2012

Official wording

Reason: 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

Code information: 100903ru, 100924rr, 101022sc, 110114sh, 110225ru

Distribution pattern: Worldwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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