Recall Z-2357-2019
Cambridge Sensors Limited · initiated July 26, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Microdot Xtra blood glucose test strips
Codes / lots: LOT NUMBERS 7091101, 7091201, 7091801, 7091902, 7100402, 7100403, 7101002, 7101602, 7101702, 7102403, 7103002, 7110602, 7110703, and 7112702.
Reason for recall
The firm reported that a faulty cutting/punching machine did not meet specifications after being fitted with new blades and did not correctly "notch" BG test strips intended for use in the US. The impacted strips did not fit into the inlet port of the BG meter, therefore resulting in a delay in BG testing and results.
FDA-determined cause: Nonconforming Material/Component
Action taken
On July 26, 2018, the firm sent an email to it's US distributor that requested a sub-recall.
Details
- Recall number
- Z-2357-2019
- Initiated
- July 26, 2018
- Product code
- NBW – System, Test, Blood Glucose, Over The Counter
- Quantity
- 17,784 (USA)
- Distribution
- Illinois
- Recalling firm
- Cambridge Sensors Limited, Huntingdon