Elecsys PreciControl Varia 3
FDA device recall Z-2173-2017 · posted 2017-05-31 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corporation
- Reason for recall
- e-barcode and value sheet for PreciControl Varia contains a typographical error for the target values for the Elecsys PTH (parathyroid hormone) and Elecsys PTH STAT immunoassays
- Action taken
- On 4/10/2017, URGENT MEDICAL DEVICE CORRECTION notifications were sent to the affected consignees via courier. The recall notifications included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about the information contained in this UMDC.
- Root cause
- Process control
- Status
- Terminated
- Product code
- JJY
- Quantity affected
- 1603
- Distribution
- Nationwide
- Date initiated
- 2017-04-10
- Date posted
- 2017-05-31
- Date terminated
- 2017-08-04
- Location
- Indianapolis, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ELECSYS PRECICONTROL VARIA 3 (K111506) | Roche Diagnostics | 2011-07-08 |