Cannabinoids DAU Calibrator Control Level 1 (37.5 ng/mL) This solution is prepared from non-sterile urine and should be
FDA device recall Z-1178-2014 · posted 2014-03-12 · Terminated
Recall details
- Recalling firm
- Lin-Zhi International Inc
- Reason for recall
- Product catalog #s 0007c Cannabinoid 37.5 ng/mL Control Level 1 and 0008c Cannabinoid 62.5 Control Level 2 of the lots mentioned may give decreased concentration readings towards the end of their shelf life due to use of dated but unexpired secondary stock used to create the products.
- Action taken
- Lin-Zhi International, sent an Recall letter dated February 6, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The Recall letter identified the product by catalog number and product description as well as lot numbers. The reason for recall is explained and that the issue was confirmed by Lin Zhi Quality Control. The 2 affected lots were made with unexpired but dated secondary stock that is the cause of the problem. Lin Zhi requests that customers inform laboratories and customers to properly dispose of any of the affected lots that are still in use or unopened. Lin Zhi should be notified of the amounts for credit. Questions should be directed to 408-732-3883.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- DLJ
- Quantity affected
- 130 items
- Distribution
- US Distribution including the states of SC, NC, LA, FL, TX,, AL and GA and Internationally to Germany.
- Date initiated
- 2014-02-06
- Date posted
- 2014-03-12
- Date terminated
- 2015-03-10
- Location
- Sunnyvale, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CANNABINOID URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS (K021449) | Lin-Zhi International, Inc. | 2002-06-18 |