FDA Medical Device Recalls (openFDA)
Diagnostica Stago, Inc.: Neoplastine Cl Plus @ (ref.00374) Product Usage: Manual or automated determination of the prothrombin time (PT).
- Recall number
- Z-1066-2018
- Recalling firm
- Diagnostica Stago, Inc.
- Product
- Neoplastine Cl Plus @ (ref.00374) Product Usage: Manual or automated determination of the prothrombin time (PT).
- Status
- Terminated
- Initiated
- 2017-10-25
- Posted
- not on file
- Terminated
- 2020-05-12
- Reason
- Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%).
- Root cause
- Device Design
- Action
- Stago sent an Urgent Field Safety Notice letter dated October 25, 2017 to their customers. The letter identified the affected product, problem and actions to be taken: Customers were instructed to: If it is not already done, run a Quality Control test at every change of vial (if you have affected lots of product). Return to company, by fax or email, an acknowledgement form confirming that the recall letter was read by the receiving company. For questions contact the Stago Hotline (1-800-725-0607).
- Quantity
- 1636 Kits
- Distribution
- Nationally
- Lot, serial or model codes
- Lot 115080 (Exp: 01-2018) Lot 251241 (Exp: 01-2018)
- 510(k) numbers
- ["K922040"]
- PMA numbers
- not on file
- Product code
- GJS
- Firm FEI
- 2245451
- Firm city
- Parsippany
- Firm state
- NJ
- 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