FDA Medical Device Recalls (openFDA)
Tripath Imaging, Inc.: Manual Method 1: 480 Test Kit (PreCoat), Catalog/Model # 490529
- Recall number
- Z-1814-2012
- Recalling firm
- Tripath Imaging, Inc.
- Product
- Manual Method 1: 480 Test Kit (PreCoat), Catalog/Model # 490529
- Status
- Terminated
- Initiated
- 2012-03-22
- Posted
- 2012-06-15
- Terminated
- 2012-12-03
- 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
- Root cause
- Component design/selection
- Action
- BD Diagnostics sent a "BD PrepMate Syringing Pipette" letter dated March 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The firm encouraged customers to refer to the Operator's Manual and inspect the centrifuge tubes to verify that the correct amount of sample has been transferred. Customers experiencing this issue were instructed to discard the pipettes and contact BD Diagnostic Technical Support for a replacement. Contact the firm at 1-877-822-7771 for questions regarding this notice.
- Quantity
- 46,112,784 for all products in Recall Event
- Distribution
- Worldwide Distribution.
- Lot, serial or model codes
- 100903ru, 100924rr, 101022sc, 110114sh, 110225ru
- 510(k) numbers
- not on file
- PMA numbers
- ["P970018"]
- Product code
- MKQ
- Firm FEI
- 3008007472
- Firm city
- Burlington
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28