Recalls / —
—#100487
Product
ACCU-CHECK PERFORMA STRIP NO. 05987288031, 100 BANDELETTES REACTIVES, ROCHE DIAGNOSTICS GMBH, WWW.ACCUCHEK.COM glucose monitoring test strips.
- FDA product code
- NBW — System, Test, Blood Glucose, Over The Counter
- Device class
- Class 2
- Medical specialty
- Clinical Chemistry
- Affected lot / code info
- Lot Number 470049, expiration date 12/31/2011.
Why it was recalled
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.
Root cause (FDA determination)
Component design/selection
Action the firm took
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
Recalling firm
- Firm
- Roche Diagnostics Operations, Inc.
- Address
- 9115 Hague Road, Indianapolis, Indiana 46256-1025
Distribution
- Distribution pattern
- No US distribution, in France Only.
Timeline
- Recall initiated
- 2011-05-18
- Posted by FDA
- 2011-06-21
- Terminated
- 2011-10-25
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #100487. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.