Elecsys PreciControl Varia 3
This recall has been terminated (originally issued May 31, 2017).
- Company
- Roche Diagnostics Corporation
- Recall Initiated
- April 10, 2017
- Posted
- May 31, 2017
- Terminated
- August 4, 2017
- Recall Number
- Z-2173-2017
- Quantity
- 1603
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
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
Distribution
Nationwide
Lot / Code Info
Lot Number: 189285 Expiration Date: 10/31/2017 Part Number: PreciControl Varia: 05618860160
Root Cause
Process control
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.