🔍 RecallPedia

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).

Class I - Dangerous
🏥 Medical Devices Recalled: July 24, 2018 Diagnostica Stago Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Diagnostica Stago, Inc.
Reason for Recall:
QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %)
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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).

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2993-2018

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STA-Liquid Anti-Xa 4. Model/Catalog Number: 00311US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite analyzers, for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate.

Diagnostica Stago

Class I - Dangerous

Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.

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