Recall Z-1814-2012— Tripath Imaging, Inc.
Class III · Terminated
Class III FDA medical device recall by Tripath Imaging, Inc., initiated 2012-03-22, terminated 2012-12-03. FDA's recall record names no specific 510(k) clearance for this event. Product: Manual Method 1: 480 Test Kit (PreCoat), Catalog/Model # 490529. 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.
- Recalling firm
- Tripath Imaging, Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2012-03-22
- Terminated
- 2012-12-03
- Firm location
- Burlington, NC, United States
Product description
Manual Method 1: 480 Test Kit (PreCoat), Catalog/Model # 490529
Reason for recall
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.