Accu-Chek SmartView Test Strips May Open During Shipment
Roche is recalling Accu-Chek SmartView Test Strip vials that may open during shipment. The vials can be exposed to humidity, damaging the strips and potentially causing inaccurate glucose readings.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is a risk-of-harm medical device recall affecting critical diabetes care equipment. Although no illnesses or injuries have been reported, the potential for inaccurate glucose readings could lead to inappropriate therapy and adverse health consequences. The FDA Class II designation and theoretical nature of the hazard support a High severity rating.
Plain-English summary
Roche Diabetes Care, Inc. is recalling Accu-Chek SmartView Test Strip vials (models 06337538001, 06337546001, 06337562001) due to a packaging defect. Approximately 1,150,755 units have been distributed in the US.
During shipment, test strip vials may open while inside sealed cartons. When a vial opens, the test strips inside may be exposed to humidity, which can damage the strips and result in inaccurate glucose readings.
Inaccurate test results could lead to patients making inappropriate therapy decisions based on incorrect blood glucose measurements, potentially causing adverse health consequences.
The recalled product
- Product
- Accu-Chek SmartView Test Strip, Blood Glucose Monitoring System, Model numbers: 06337538001, 06337546001, 06337562001
- Manufacturer
- Roche Diabetes Care, Inc.
- Affected units
- 1,150,755
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 (2)
- Since this is a labeling correction
- this recall is not lot specific and is applicable to all non-expired lots.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 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 4 products in this recall →Related recalls
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