Cambridge Sensors Recalls Microdot Xtra Blood Glucose Test Strips
Cambridge Sensors Limited is recalling Microdot Xtra blood glucose test strips in Illinois because faulty manufacturing equipment prevented the strips from fitting into the meter.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a functional defect causing testing delays rather than a direct risk of serious injury or death, aligning with the Moderate severity criteria for low-risk issues.
Plain-English summary
Cambridge Sensors Limited is recalling 17,784 units of Microdot Xtra blood glucose test strips distributed in Illinois. The recall is due to a faulty cutting and punching machine that did not meet specifications after being fitted with new blades. As a result, the strips were not correctly notched for use in the United States.
The manufacturing defect caused the impacted strips to fail to fit into the inlet port of the blood glucose meter. This issue resulted in a delay in blood glucose testing and the acquisition of results. The affected lot numbers are 7091101, 7091201, 7091801, 7091902, 7100402, 7100403, 7101002, 7101602, 7101702, 7102403, 7103002, 7110602, 7110703, and 7112702.
Consumers who have these specific lot numbers of Microdot Xtra blood glucose test strips should stop using them and contact the recalling firm for instructions on how to proceed.
The recalled product
- Product
- Microdot Xtra blood glucose test strips
- Manufacturer
- Cambridge Sensors Limited
- Hazard
- Affected units
- 17,784
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 (14)
- LOT NUMBERS 7091101
- 7091201
- 7091801
- 7091902
- 7100402
- 7100403
- 7101002
- 7101602
- 7101702
- 7102403
- 7103002
- 7110602
- 7110703
- and 7112702.
Distribution
Distributed in 1 state:
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