Catalog Number 04625315003 |
Device Problems
Inadequate or Insufficient Training (1643); Device Markings/Labelling Problem (2911); Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/10/2022 |
Event Type
malfunction
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Event Description
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The customer state the information on the label of their test strip box does not match the information on the strip vial label.Customer stated the box label states the test strips are lot 56099311 with expiration date 31-mar-2023.The customer stated the test strip vial label states the strips are lot 45392511 with expiration date 30-sep-2020.
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Manufacturer Narrative
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The investigation is ongoing.
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Manufacturer Narrative
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The production process and production dates were investigated.It is not possible for test strip lot 45392511 expiration: 30-sep-2020 to be packed in an outer packaging of test strips that do not expire until 2023.The time difference of 3 years between expiry date of test strip vials and package is impossible.Retention material contains the correct code key.
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Search Alerts/Recalls
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