Single Analyte Urine DAU Control recall: Impurity Out of Spec
Single Analyte Urine DAU Control (5 m L Norbuprenorphine, Level II control For In Vitro Diagnostic Use Only. store at 2 - 8 degrees C. Contents…
Why was Single Analyte Urine DAU Control recalled?
Product catalog # A68825 Norbuprenorphine 13 ng/mL Level 2 Controls gives a decreased concentration reading due to the degradation of the NBUP analyte in solution.
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?
Catalog #A68825, Lot #1307086; Exp. 3/28/2014/
- Product
- Single Analyte Urine DAU Control (5 m L Norbuprenorphine, Level II control For In Vitro Diagnostic Use Only. store at 2 - 8 degrees C. Contents…
- Recalling firm
- Lin-Zhi International Inc
- Quantity
- 60 items
- Distribution
- US Distribution in CA.
- Recall date
- December 4, 2013
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)