Accu-Chek Comfort Curve glucose test strips; part numbers 2030420, 2030365, 2030373, 2030381, 3000133 and 3000141.
FDA Recall Z-0715-03 · Posted 2003-04-09
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Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Product CodeLFR
Date Initiated2003-02-12
Date Terminated2003-09-15
Reason for Recall
Crack in the bottom of the test strip vial will cause erroneously low or high blood glucose readings.
Firm Action
Urgent Product Correction letters dated 2/12/03 were issued to pharmacists, specific health care providers, and the laboratory manager at customer accounts. Letter recipients were asked to advise their patients to inspect their vial for a crack prior to each use.
Root Cause
Other
Distribution Pattern
United States, Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Denmark, Finland, France, Germany, Guatemala, Honduras, Hong Kong, Indonesia, Japan, Malaysia, Mexico, New Zealand, Norway, Pakistan, Peru, Philippines, Portugal, Singapore, South Africa, South Korea, Spain, Taiwan, Thailand, United Kingdom and Vietnam.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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