—#32194

Product

Coag-A-Mate MTX and MTX II Instrument Operator Manual

FDA product code: GKP — Instrument, Coagulation, Automated
Device class: Class 2
Medical specialty: Hematology
Affected lot / code info: All Codes

Why it was recalled

Typographical error in the Operator Manual. In Chapter 11 of the MTX/MTX II Operator Manual, the numerical range for the Warning Flag is shown as 00-99. The correct numerical range is 0-99. The 'list of error and warning' chart shows a numerical range representing the codes 00-9. The correct numerical range for the first ten error/warning codes are 0-9.

Root cause (FDA determination)

Other

Action the firm took

Consignees were notified by letter on September 29, 2003.

Recalling firm

Firm: Biomerieux, Inc.
Address: 100 Rodolphe St, Durham, North Carolina 27712-9402

Distribution

Distribution pattern: Nationwide, Argentina, Australia, Austria, Belgium, Brazil, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Finland, France, Germany, Greece, HK, India, Italy, Ivory Coast, Japan, Korea, Mexico, Netherlands, N. Zealand, Norway, Poland, Portugal, Russia, Spain, Sweden, Switzerland, Turkey, UK.

Timeline

Recall initiated: 2003-09-29
Posted by FDA: 2004-07-20
Terminated: 2005-06-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #32194. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.