PrepStain PM Kit, T-AG (Catalog 490588); PrepStain PM Kit Europe (Catalog 490671); PrepStain Prep Only PM Kit, T-AG (Cat
FDA device recall Z-2088-2012 · posted 2012-07-26 · Terminated
Recall details
- Recalling firm
- Tripath Imaging, Inc.
- Reason for recall
- Some Prep Stain Kit, 1.2 DiTi Cones have been found to be leaking and the PrepStain Preparation kits contain incorrect preventive maintenance (PM) instructions.
- Action taken
- BD Diagnostics sent a letter dated March 2012 to all affected customers. The letter identifies the product, problem and actions that will be taken by the firm. Contact BD Diagnostics Technical Support at 1-877-822-7771, option 2 for questions regarding this letter.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- MKQ
- Quantity affected
- 1166 units
- Distribution
- Worldwide Distribution-USA (nationwide) including Puerto Rico and the states AL, AK, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ,
- Date initiated
- 2011-12-08
- Date posted
- 2012-07-26
- Date terminated
- 2013-11-08
- Location
- Burlington, NC
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