Recalls / —
—#37745
Product
Roche CoaguChek System Controls; Catalog number 7745, Part numbers 054207608 and 04393201001.
- FDA product code
- GJS — Test, Time, Prothrombin
- Device class
- Class 2
- Medical specialty
- Hematology
- 510(k) numbers
- K930454, K942884, K952625, K974569
- Affected lot / code info
- All lots.
Why it was recalled
Breaking the glass ampoule without first taking precautions may result in cuts/user injury from the glass.
Root cause (FDA determination)
Other
Action the firm took
Consignees were notified via letter dated 3/28/05 and were provided new ampoule breakage precautions/ instructions.
Recalling firm
- Firm
- Roche Diagnostics Corp.
- Address
- 9115 Hague Rd, Indianapolis, Indiana 46256-1025
Distribution
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2005-03-28
- Posted by FDA
- 2005-10-28
- Terminated
- 2006-04-06
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #37745. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.