Recall Z-1178-2014 ยท DLJ Calibrators, Drug Specific
Lin-Zhi International Inc
Cannabinoids DAU Calibrator Control Level 1 (37.5 ng/mL) This solution is prepared from non-sterile urine and should be handled as potentially infectious. IVD; The Cannabinoids (cTHC also known as THC version c) DAU negative and positive controls are human urine-based liquids and ready to use. The constituent is a processed drug-free human urine matrix, containing buffers, stabilizers, and less
| Date | Mar 12, 2014 (initiated Feb 6, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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 t |
| Quantity | 130 items |
| Distribution | US Distribution including the states of SC, NC, LA, FL, TX,, AL and GA and Internationally to Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021449 | CANNABINOID URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS Lin-Zhi International, Inc., Jun 18, 2002 |