FDA Medical Device Recalls (openFDA)
Roche Diagnostics Corporation: Elecsys PreciControl Varia 3
- Recall number
- Z-2173-2017
- Recalling firm
- Roche Diagnostics Corporation
- Product
- Elecsys PreciControl Varia 3
- Status
- Terminated
- Initiated
- 2017-04-10
- Posted
- 2017-05-31
- Terminated
- 2017-08-04
- Reason
- 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
- Root cause
- Process control
- 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.
- Quantity
- 1603
- Distribution
- Nationwide
- Lot, serial or model codes
- Lot Number: 189285 Expiration Date: 10/31/2017 Part Number: PreciControl Varia: 05618860160
- 510(k) numbers
- ["K111506"]
- PMA numbers
- not on file
- Product code
- JJY
- Firm FEI
- 1823260
- Firm city
- Indianapolis
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28