FDA Device

CoaguChek brand PT Test Strips; U.S. Catalog Number 3116247 (48 strip pack-professional use).

Hazard

The product was erroneously distributed to home users in contrast to its use for healthcare professionals only.

What You Should Do

Remedy

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.

Products

CoaguChek brand PT Test Strips; U.S. Catalog Number 3116247 (48 strip pack-professional use).
Brand
Roche Diagnostics Corp.
UPC
Lots 469A and 475A; exp. 6/30/2008.

Units Affected

10