Product Safety Recalls

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Roche Diabetes Care, Inc. Recall 88362

Description: Accu-Chek Aviva Plus Test Strip, Blood Glucose Monitoring System, Model numbers: 06908152001, 06908217001, 06908268001, 06908349001, 06908373001

Roche Diabetes Care, Inc. Recall 88362 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2351-2021
Event ID88362
Event DescriptionAccu-Chek Aviva Plus Test Strip, Blood Glucose Monitoring System, Model numbers: 06908152001, 06908217001, 06908268001, 06908349001, 06908373001
Product TypeDevices
DistributionWorldwide distribution - US Nationwide distribution.
Quantity10,546,420 (US), 19,120,668 (OUS)
Recall ReasonTest 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.
Device Classification20210901
Device Code InfoSince this is a labeling correction, this recall is not lot specific and is applicable to all non-expired lots.
Center Classification Date20210826
Recall Initiation Date20210728
Recalling FirmRoche Diabetes Care, Inc.
Initial Notification Letter
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