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Terminated

ACCU-CHECK PERFORMA STRIP NO. 05987288031, 100 BANDELETTES REACTIVES, ROCHE DIAGNOSTICS GMBH, WWW.ACCUCHEK.COM glucose monitoring test strips.

FDA Recall Z-2570-2011 · Posted 2011-06-21

Recalling FirmRoche Diagnostics Operations, Inc.
Recall StatusTerminated
Product CodeNBW
Date Initiated2011-05-18
Date Terminated2011-10-25
Product Quantity27,019 units

Reason for Recall

Erroneous results: Internal investigations revealed that the test strips exhibited a performance issue that can cause test strip errors or a bias in test result that exceed the tolerance range according to EN ISO 15197.

Firm Action

Direct accounts were notified by a Roche Diagnostics press release on 5/18/2011 that included the product's name, lot number, and information to withdraw the remaining inventory of lot 470049 from storage

Root Cause

Component design/selection

Distribution Pattern

No US distribution, in France Only.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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