Roche Diagnostics Corp. Accu-Chek Inform blood glucose test strips; Reference numbers 04535057001, 04647696001 and 04535120001 (All sold outside of the United States). Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Accu-Chek Inform blood glucose test strips; Reference numbers 04535057001, 04647696001 and 04535120001 (All sold outside of the United States).
Brand
Roche Diagnostics Corp.
Lot Codes / Batch Numbers
All lots.
Products Sold
All lots.
Roche Diagnostics Corp. is recalling Accu-Chek Inform blood glucose test strips; Reference numbers 04535057001, 04647696001 and 045351200 due to There may be a thin piece of plastic across the mouth of the vial, preventing the cap from sitting snugly onto the vial and, if present, this situatio. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There may be a thin piece of plastic across the mouth of the vial, preventing the cap from sitting snugly onto the vial and, if present, this situation will cause erroneously low or high blood glucose readings..
Recommended Action
Per FDA guidance
Notifications (letters) dated 2/10/06 were sent to healthcare professionals, retail pharmacies, hospitals and mail order firms asking them to provide their customers with information instructing the users to inspect their strip vials and to not use strips from defective vials. Mail order accounts were instructed to forward the recall notification to end users.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026