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Recall Observatory FDA recall evidence

Device product

Accu-Chek Performa Test Strip, Blood Glucose Monitoring System, Model number 07299702001

Z-2352-2021

July 28, 2021

Class II

Product summary

Firm
Roche Diabetes Care, Inc.
Event
Event 88362
Status
Ongoing
Classification
Class II
Quantity
146,854 (US); 59,815,555 (OUS)
Official record key
device-enforcement:Z-2352-2021

Official wording

Reason: Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and result in inaccurate results, potentially leading to inappropriate therapy decisions and adverse health consequences.

Code information: Since this is a labeling correction, this recall is not lot specific and is applicable to all non-expired lots.

Distribution pattern: Worldwide distribution - US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and result in inaccurate results, potentially leading to inappropriate therapy decisions and adverse health consequences.