CLASS II Device recall · Reported 19 Sep 2018 · FDA Enforcement Report
STA N¿oplastine¿ CI Plus vial recalled by Diagnostica Stago
Diagnostica Stago is recalling STA N¿oplastine¿ CI Plus vial, distributed nationwide in the US. The recall was initiated on 24 Jul 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2993-2018
- FDA event ID
- 80826
- Recalling firm
- Diagnostica Stago, Parsippany, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Jul 2018
- FDA classified
- 7 Sep 2018
- Reported
- 19 Sep 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 24 Jul 2018 | Recall initiated by company | |
| 7 Sep 2018 | Classified by FDA | +45 days |
| 19 Sep 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %)
Product as listed by the FDA
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).
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %)
Which lots are affected?
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
Where was it sold?
Nationwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 80826This product is part of a recall event; the main page for the event is STA N¿oplastine¿ CI vial recalled by Diagnostica Stago.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | STA N¿oplastine¿ CI vial recalled by Diagnostica Stago | Diagnostica Stago | Other | Nationwide |
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