Roche Recalls Accu-Chek Performa Test Strips Due to Potential Measurement Errors
Roche Diabetes Care is recalling Accu-Chek Performa test strips because they may produce biased results or fail to detect blood samples, potentially leading to incorrect user actions.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where biased results could lead to incorrect user actions, representing a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Roche Diabetes Care, Inc. is recalling Accu-Chek Performa Test Strips (Catalog no. 07299702001) used with the Accu-Chek Performa meter to measure glucose in venous or capillary whole blood. The recall involves 295,248 units distributed worldwide, including nationwide distribution in the United States and to numerous foreign countries.
The recalling firm identified two lots of test strips that are out of specification. These affected strips show an increased potential for strip errors prior to applying a blood sample, failure to be detected once inserted, or the occurrence of biased results that may not be detectable. In the case of a biased result, incorrect action could be taken by the user in response to the displayed blood glucose result as compared to the actual blood glucose value.
Consumers should stop using the affected test strips and contact Roche Diabetes Care for further instructions or a replacement.
The recalled product
- Product
- Accu-Chek Performa Test Strip, Blood glucose monitoring system, Catalog no. 07299702001 Product Usage: The Accu-Chek Performa test strips are for use with the Accu-Chek Performa meter to quantitatively measure glucose (sugar) in venous whole blood or fresh capillary whole blo
- Manufacturer
- Roche Diabetes Care, Inc.
- Affected units
- 295,248
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot 476605
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Roche Diabetes Care, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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