Diagnostica Stago STA N¿oplastine¿ CI Plus recall
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…
Why was Diagnostica Stago STA N¿oplastine¿ CI Plus recalled?
QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %)
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models 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
- 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…
- Recalling firm
- Diagnostica Stago, Inc.
- Quantity
- 24043 kits
- Distribution
- Nationwide
- Recall date
- September 19, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)