FDA Device

Roche CoaguChek System Controls (patient self testing); Catalog number 763, Part numbers 054200705 and 047514003.

Hazard

Breaking the glass ampoule without first taking precautions may result in cuts/user injury from the glass.

What You Should Do

Remedy

Consignees were notified via letter dated 3/28/05 and were provided new ampoule breakage precautions/ instructions.

Products

Roche CoaguChek System Controls (patient self testing); Catalog number 763, Part numbers 054200705 and 047514003.
Brand
Roche Diagnostics Corp.
UPC
All lots.

Units Affected

unknown.