ACCU-CHECK PERFORMA STRIP NO. 05987288031, 100 BANDELETTES REACTIVES, ROCHE DIAGNOSTICS GMBH, WWW.ACCUCHEK.COM glucose m
FDA device recall Z-2570-2011 · posted 2011-06-21 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Operations, Inc.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- NBW
- Quantity affected
- 27,019 units
- Distribution
- No US distribution, in France Only.
- Date initiated
- 2011-05-18
- Date posted
- 2011-06-21
- Date terminated
- 2011-10-25
- Location
- Indianapolis, IN
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