FDA Medical Device Recalls (openFDA)
Diagnostica Stago, Inc.: Diagnostica Stago STA Noplastine CI, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma. REF: 00666 The STA - Noplastine CI kits provide reagents for the determination of the prothrombin time (PT) in plasma with STA-R, STA Compact and STA Satellite. (In the USA this procedure has been assigned to the moderate complexity category per CLIA 1988 - CDC Analyte Code 4922; CDC Test System Codes 4677 and 4875).
- Recall number
- Z-2994-2018
- Recalling firm
- Diagnostica Stago, Inc.
- Product
- Diagnostica Stago STA Noplastine CI, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma. REF: 00666 The STA - Noplastine CI kits provide reagents for the determination of the prothrombin time (PT) in plasma with STA-R, STA Compact and STA Satellite. (In the USA this procedure has been assigned to the moderate complexity category per CLIA 1988 - CDC Analyte Code 4922; CDC Test System Codes 4677 and 4875).
- Status
- Terminated
- Initiated
- 2018-07-24
- Posted
- not on file
- Terminated
- 2020-05-18
- Reason
- QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %)
- Root cause
- Device Design
- Action
- Diagnostica Stago issued notification on July 24, 2018 to US Customers provided the reason for the notification, actions to be taken to mitigate the risk. Action: If you have in your laboratory, any of the lots among those listed in the appendix, we are asking you to: If it is not already done, run a Quality Control test at every change of vial. Return to your Stago affiliate, by fax or e-mail, the enclosed form completed and confirming that you have read this letter. Questions contact Stago Hotline (1-800-725-0607)
- Quantity
- 5 kits
- Distribution
- Nationwide
- Lot, serial or model codes
- Lot Number/Exp. Date/UDI 251426 2018-11-30 (01)03607450006667(11)161130(17)181130(10)251426(241)00666; 251763 2019-02-28 (01)03607450006667(11)170228(17)190228(10)251763(241)00666
- 510(k) numbers
- ["K922565"]
- 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