Roche Diagnostics Corp. CoaguChek brand PT Test Strips; U.S. Catalog Number 3116247 (48 strip pack-professional use). Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CoaguChek brand PT Test Strips; U.S. Catalog Number 3116247 (48 strip pack-professional use).
Brand
Roche Diagnostics Corp.
Lot Codes / Batch Numbers
Lots 469A and 475A, exp. 6/30/2008.
Products Sold
Lots 469A and 475A; exp. 6/30/2008.
Roche Diagnostics Corp. is recalling CoaguChek brand PT Test Strips; U.S. Catalog Number 3116247 (48 strip pack-professional use). due to The product was erroneously distributed to home users in contrast to its use for healthcare professionals only.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The product was erroneously distributed to home users in contrast to its use for healthcare professionals only.
Recommended Action
Per FDA guidance
All consignees were notified by telephone on/or about 2/28/07 and some received a follow-up letter dated 3/2/07 or 3/5/07.
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