Recall Z-1815-2012— 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: PrepStain GN 480 Disposable Kit Catalog/Model 490542 This is a complete kit, per the firm's explanation, that contains the PrepStain Syringing Pipettes 240, the product being recalled. The affected lots are listed under those pipettes (PrepStain Syringing Pipettes 240). 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
PrepStain GN 480 Disposable Kit Catalog/Model 490542 This is a complete kit, per the firm's explanation, that contains the PrepStain Syringing Pipettes 240, the product being recalled. The affected lots are listed under those pipettes (PrepStain Syringing Pipettes 240)
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.