Z-2173-2017 Class II Terminated
FDA device recall Z-2173-2017 was initiated by Roche Diagnostics Corporation on April 10, 2017 and is designated Class II. 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 The recall status is terminated (terminated August 4, 2017). Affected quantity: 1603.
Recall Details
- Product Type
- Devices
- Report Date
- June 7, 2017
- Initiation Date
- April 10, 2017
- Termination Date
- August 4, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1603
Product Description
Elecsys PreciControl Varia 3
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 Pattern
Nationwide
Code Information
Lot Number: 189285 Expiration Date: 10/31/2017 Part Number: PreciControl Varia: 05618860160