STA - Neoplastine¿ Cl ¿ recall
STA - Neoplastine¿ Cl ¿ (ref. 00605) Product Usage: Manual or automated determination of the prothrombin time (PT).
Why was STA - Neoplastine¿ Cl ¿ recalled?
Confirmed defect of homogeneity where some reagent vials will give 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 251064 (Exp: 09-2018) Lot 251725 (Exp: 02-2019)
- Product
- STA - Neoplastine¿ Cl ¿ (ref. 00605) Product Usage: Manual or automated determination of the prothrombin time (PT).
- Recalling firm
- Diagnostica Stago, Inc.
- Distribution
- Nationally
- Recall date
- March 21, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)