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OneTouch Verio
LifeScan Europe GmbH · Model 013-046 · UDI-DI 00353885012423
10
510(k) clearances
74,380
Adverse events (33 deaths)
51
Recalls
67
Facilities
Description
OneTouch Verio Test Strips. For Blood glucose testing with OneTouch Verio Family of Meters. For in vitro diagnostic use. For self-testing.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-07-28 | Roche Diabetes Care, Inc. | Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and result in inaccurate |
| 2021-07-28 | Roche Diabetes Care, Inc. | Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and result in inaccurate |
| 2018-05-07 | Roche Diabetes Care, Inc. | The recalling firm identified four US lots of test strips out of specification. Affected strips show increased potential for strip errors prior to applying blood, strips not detect |
| 2018-05-07 | Roche Diabetes Care, Inc. | The recalling firm has identified two lots of test strips that are out of specification. Affected test strips show an increased potential for: strip errors prior to applying a bloo |
| 2018-05-07 | Roche Diabetes Care, Inc. | The recalling firm has identified two lots of test strips that are out of specification. Affected test strips show an increased potential for: strip errors prior to applying a bloo |
| 2016-02-11 | Roche Diagnostics Operations, Inc. | Accu-Chek Inform II Base Unit might produce physical transmission errors in the form of data loss in the communication between the meter and the Data Management Systems (DMS). The |
| 2012-02-21 | Lifescan Inc | An error was discovered in the OneTouch IQ meter software so that the meter turns itself off when a user attempts to view results in the "Results Log" when the log has 256 or a mul |
| 2011-08-12 | Bayer Healthcare, LLC | All 10- or 25- count glucose test strip vials, either loose vials or found in patient starter kits of Contour, Contour TS and Contour" USB blood glucose meters are being recalled a |
| 2009-05-13 | Roche Diagnostics Corp. | The lancet cap may be missing, which could result in an unintended lancet stick to the user. |
| 2009-05-13 | Roche Diagnostics Corp. | The lancet cap may be missing, which could result in an unintended lancet stick to the user. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.