The accu-chek inform ii meter serial number was (b)(6).The test strips were requested for investigation.The product has not been received at this time.If the product is returned in the future, a follow-up report will be submitted.On a regular basis, accu-chek inform strips of lots currently valid in the market are tested as part of routine retention testing and results have passed the internal inspection.
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The meter was received for investigation on 09-may-2024 where it was tested using retention strips and controls.Control ranges: level 1: 30-60 mg/dl.Level 2: 261-353 mg/dl.Results: level 1: 46, 44, 44 mg/dl.Level 2: 308, 304, 312 mg/dl.All returned results are within the acceptable range.A visual investigation of the meter was performed.During the investigation, contamination within the strip port was identified.The investigation did not identify a product problem.The root cause was due to contamination within the strip port.
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