The Recall Desk
ModerateFDA (Devices)·Z-2993-2018·Announced 2018-09-19

Diagnostica Stago Recalls STA N¿oplastine¿ CI Plus Reagents Due to Quality Control Failures

Diagnostica Stago is recalling 24,043 kits of STA N¿oplastine¿ CI Plus reagents because quality control values fell outside assigned ranges, potentially affecting prothrombin time test results.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which indicates a situation that could temporarily cause or contribute to reversible adverse health consequences. The source text does not report any specific injuries, illnesses, or fatalities, and the hazard is related to potential diagnostic inaccuracy rather than direct physical harm.

Plain-English summary

Diagnostica Stago, Inc. is recalling 24,043 kits of STA N¿oplastine¿ CI Plus, 10 ml vials. These are in-vitro diagnostic reagents used to determine prothrombin time (PT) in plasma. The affected lots were distributed nationwide.

The recall was initiated because quality control values were found to be outside of the assigned ranges, specifically showing prolonged Prothrombin time or decreased PT %. This defect may result in inaccurate test results for patients undergoing prothrombin time testing.

Healthcare facilities and laboratories should stop using the affected lots immediately. Users should check their inventory against the specific lot numbers and expiration dates listed in the recall notice. For more information, contact Diagnostica Stago, Inc. or refer to the FDA recall record Z-2993-2018.

The recalled product

Product
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¿,
Manufacturer
Diagnostica Stago, Inc.
Category
Medical Device — In-Vitro Diagnostic
Hazard
Affected units
24,043

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (13)

  • 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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Diagnostica Stago, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

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