Diagnostica Stago STA Noplastine CI 10ml Vial Recall: Prothrombin Time Errors
Diagnostica Stago recalls STA Noplastine CI 10ml vials for potential prothrombin time measurement errors. Affected units have QC values outside assigned ranges, requiring immediate action.
Lower-risk recall
QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %)
Contact the company
What happened, in plain English
Diagnostica Stago is recalling its STA Noplastine CI 10ml vial products due to potential prothrombin time measurement errors. This could lead to inaccurate blood clotting tests, which may affect medical decisions if used without proper correction. Read more at govinfonow.com/recall/70297-diagnostica-stago-sta-noplastine-ci-10ml-vial-recall-prothrombin-time.
Source Summary by GovInfoNow · govinfonow.com/recall/70297-diagnostica-stago-sta-noplastine-ci-10ml-vial-recall-prothrombin-time · Updated August 20, 2026 · FDA enforcement record: FDA #Z-2994-2018
Cite this page
“Diagnostica Stago STA Noplastine CI 10ml Vial Recall: Prothrombin Time Errors.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/70297-diagnostica-stago-sta-noplastine-ci-10ml-vial-recall-prothrombin-time. Based on FDA recall #Z-2994-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2994-2018%22&limit=1).
Why it’s dangerous
The vials may produce QC values outside the assigned ranges, causing prolonged prothrombin time or decreased PT percentages. This could lead to inaccurate blood clotting test results, potentially affecting medical treatment decisions.
Who’s affected
Healthcare professionals using these vials for blood clotting tests are most at risk. Patients receiving these tests may be affected if the results are inaccurate.
How to tell if you have this one
Check for lot numbers 251426 (expiring November 2018) or 251763 (expiring February 2019) on the vial packaging. The product is sold under the brand Diagnostica Stago.
- Brand
Diagnostica Stago- Product
Diagnostica Stago STA N¿oplastine¿ CI, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT)- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2993-2018 | Diagnostica Stago STA N¿oplastine¿ CI Plus, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma. (REF 00667) The STA¿ - N¿oplastine¿ 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).; 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 | 24043 kits |
| Z-2994-2018 | Diagnostica Stago STA N¿oplastine¿ CI, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma. REF: 00666 The STA¿ - N¿oplastine¿ 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).; 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 | 5 kits |
What to do — step by step
Check Vial Details
Look for lot numbers 251426 (expiring November 2018) or 251763 (expiring February 2019) on the vial packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 22 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2994-2018 (July 24, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2994-2018 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.