FDA Device

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

Hazard

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.

What You Should Do

Remedy

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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Products

ACCU-CHECK PERFORMA STRIP NO. 05987288031, 100 BANDELETTES REACTIVES, ROCHE DIAGNOSTICS GMBH, WWW.ACCUCHEK.COM glucose monitoring test strips.
Brand
Roche Diagnostics Operations, Inc.
UPC
Lot Number 470049, expiration date 12/31/2011.

Units Affected

27,019 units

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