FDAClass IISeptember 19, 2018

Diagnostica Stago STA N¿oplastine¿ CI recall

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¿…

Why was Diagnostica Stago STA N¿oplastine¿ CI 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 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

Product
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¿…
Recalling firm
Diagnostica Stago, Inc.
Quantity
5 kits
Distribution
Nationwide
Recall date
September 19, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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