Single Analyte DAU Calibrator (5 mL) Norbuprenorphine: Cutoff Calibrator; IVD - for in vitro diagnostic use only; Lin-Zh
FDA device recall Z-1270-2014 · posted 2014-03-21 · Terminated
Recall details
- Recalling firm
- Lin-Zhi International Inc
- Reason for recall
- 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).
- Action taken
- 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 prevent future problems. Questions may be directed to Lin Zhi International at 408-732-3856.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- DJG
- Quantity affected
- 120 units, 60 of each lot number
- Distribution
- US Distribution including CA.
- Date initiated
- 2014-02-18
- Date posted
- 2014-03-21
- Date terminated
- 2014-04-25
- Location
- Sunnyvale, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BUPRENORPHINE ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS FOR BECKMAN COULTER SYNCHRON SYSTEMS (K081008) | Lin-Zhi International, Inc. | 2008-12-22 |