Single Analyte DAU Calibrator recall
Single Analyte DAU Calibrator (5 mL) Norbuprenorphine: Cutoff Calibrator; IVD - for in vitro diagnostic use only; Lin-Zhi International Sunnyvale, CA…
Why was Single Analyte DAU Calibrator recalled?
Customer reported that the Synchron NBUP cutoff calibrator (10 ng/mL) could not be qualified through quality control testing. The cutoff calibrator was recovering at a concentration close to the NBUP Control Level 1 (7 ng/mL).
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?
Product catalog number: A68827; Lots 1308006, 1308131, Expiry: March 28, 2015.
- Product
- Single Analyte DAU Calibrator (5 mL) Norbuprenorphine: Cutoff Calibrator; IVD - for in vitro diagnostic use only; Lin-Zhi International Sunnyvale, CA…
- Recalling firm
- Lin-Zhi International Inc
- Quantity
- 120 units, 60 of each lot number
- Distribution
- US Distribution including CA.
- Recall date
- April 2, 2014
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)