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Terminated

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

FDA Recall Z-0771-04 · Posted 2004-07-20

Recalling FirmBiomerieux, Inc.
Recall StatusTerminated
Product CodeGKP
Date Initiated2003-09-29
Date Terminated2005-06-08
Product Quantityunknown

Reason for Recall

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.

Firm Action

Consignees were notified by letter on September 29, 2003.

Root Cause

Other

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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