Multi-Analyte Urine DAU Calibrator (15 mL); Multi-Analyte,Intermediate Calibrator; for in-vitro diagnostic use only. Con
FDA device recall Z-0847-2012 · posted 2012-01-25 · Terminated
Recall details
- Recalling firm
- Lin-Zhi International Inc
- Reason for recall
- Catalog # 0804 Multi-Analyte Urine DAU Intermediate Calibrators were incorrectly labeled and mistakenly filled with Catalog # 0805 DAU High Calibrators.
- Action taken
- Lin -Zhi International sent a Recall letter dated October 11, 2011, and a e-mail to all affected customers. This was followed up by a personal phone call from Lin-Zhi personnel. The letter identified the product the problem and the action needed to be taken by the customer. The customer will be contacted to determine whether or not they were affected by this non-conformity. If they have been affected, they will be offered replacement Multi-Analyte Urine Intermediate Calibrators which are currently estimated to have a four week wait time before they become available. For further questions please call (408) 732-3856.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- DKB
- Quantity affected
- 49 items
- Distribution
- Worldwide Distribution -- USA (nationwide) including the states of NC,MA, NH and TX. and the country of Germany,
- Date initiated
- 2011-10-11
- Date posted
- 2012-01-25
- Date terminated
- 2012-01-25
- Location
- Sunnyvale, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS (K051088) | Lin-Zhi International, Inc. | 2005-06-24 |