Roche Diagnostics Corp. Roche CoaguChek S System Controls; Catalog number 3033384, part numbers 010018501 and 04393198001. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Roche CoaguChek S System Controls; Catalog number 3033384, part numbers 010018501 and 04393198001.
Brand
Roche Diagnostics Corp.
Lot Codes / Batch Numbers
All lots.
Products Sold
All lots.
Roche Diagnostics Corp. is recalling Roche CoaguChek S System Controls; Catalog number 3033384, part numbers 010018501 and 04393198001. due to Breaking the glass ampoule without first taking precautions may result in cuts/user injury from the glass.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Breaking the glass ampoule without first taking precautions may result in cuts/user injury from the glass.
Recommended Action
Per FDA guidance
Consignees were notified via letter dated 3/28/05 and were provided new ampoule breakage precautions/ instructions.
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