Recall Z-1270-2014 ยท DJG Enzyme Immunoassay, Opiates
Lin-Zhi International Inc
Single Analyte DAU Calibrator (5 mL) Norbuprenorphine: Cutoff Calibrator; IVD - for in vitro diagnostic use only; Lin-Zhi International Sunnyvale, CA The Norbuprenorphine Drug of Abuse (DAU) cutoff Calibrator is used for qualitative and semi-qualitative calibration of the Lin-Zhi Internal, Inc. Buprenorphine (BUP) enzyme Immunoassay (REF # A53684) on the Synchron Clinical Analyzer
| Date | Mar 21, 2014 (initiated Feb 18, 2014) |
| Status | Terminated |
| Reason | 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). |
| Root cause | Packaging |
| Action | Lin-Zhi International sent a Recall letter dated February 18, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Letters acknowledge that Lin Zhi was notified by the customer that the product could not be qualified and that this was confirmed by Lin-Zhi internal testing. Letters request that the distributor notify all customers of the situation and ask them to destroy any remaining product from the affected lots. the root cause is identified and letters also state that a corrective action has been implemented to pr |
| Quantity | 120 units, 60 of each lot number |
| Distribution | US Distribution including CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081008 | BUPRENORPHINE ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS FOR BECKMAN COULTER SYNCHRON SYSTEMS Lin-Zhi International, Inc., Dec 22, 2008 |