ACCU-CHECK PERFORMA STRIP NO. 05987288031, 100 BANDELETTES REACTIVES, ROCHE DIAGNOSTICS GMBH, WWW.ACCUCHEK.COM glucose monitoring test strips.
This recall has been terminated (originally issued June 21, 2011).
- Recall Initiated
- May 18, 2011
- Posted
- June 21, 2011
- Terminated
- October 25, 2011
- Recall Number
- Z-2570-2011
- Quantity
- 27,019 units
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
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.
Distribution
No US distribution, in France Only.
Lot / Code Info
Lot Number 470049, expiration date 12/31/2011.
Root Cause
Component design/selection
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
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