FDA Medical Device Recalls (openFDA)
Diagnostica Stago, Inc.: Diagnostica Stago STA Noplastine CI Plus, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma. (REF 00667) The STA - Noplastine CI Plus 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-2993-2018
- Recalling firm
- Diagnostica Stago, Inc.
- Product
- Diagnostica Stago STA Noplastine CI Plus, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma. (REF 00667) The STA - Noplastine CI Plus 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
- 24043 kits
- Distribution
- Nationwide
- Lot, serial or model codes
- Lot Number/Exp. Date/UDI 250791 2018-07-31 (01)03607450006674(11)160731(17)180731(10)250791(241)00667; 250792 2018-07-31 (01)03607450006674(11)160731(17)180731(10)250792(241)00667; 250911 2018-08-31 (01)03607450006674(11)160831(17)180831(10)250911(241)00667; 251231 2018-10-31 (01)03607450006674(11)161031(17)181031(10)251231(241)00667; 251311 2018-11-30 (01)03607450006674(11)161130(17)181130(10)251311(241)00667; 251364 2018-11-30 (01)03607450006674(11)161130(17)181130(10)251364(241)00667; 251427 2018-11-30 (01)03607450006674(11)161130(17)181130(10)251427(241)00667; 251528 2018-12-31 (01)03607450006674(11)161231(17)181231(10)251528(241)00667; 251707 2019-01-31 (01)03607450006674(11)170131(17)190131(10)251707(241)00667; 251708 2019-01-31 (01)03607450006674(11)170131(17)190131(10)251708(241)00667; 251767 2019-02-28 (01)03607450006674(11)170228(17)190228(10)251767(241)00667; 251800 2019-02-28 (01)03607450006674(11)170228(17)190228(10)251800(241)00667; 252534 2019-07-31 (01)03607450006674(11)170731(17)190731(10)252534(241)00667; 252737 2019-09-30 (01)03607450006674(11)170930(17)190930(10)252737(241)00667
- 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