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Terminated

Elecsys PreciControl Varia 3

FDA Recall Z-2173-2017 · Posted 2017-05-31

Recalling FirmRoche Diagnostics Corporation
Recall StatusTerminated
Product CodeJJY
Date Initiated2017-04-10
Date Terminated2017-08-04
Product Quantity1603

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

Firm Action

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

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K111506ELECSYS PRECICONTROL VARIA 3Roche Diagnostics · 2011-07-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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