Biomerieux, Inc. Coag-A-Mate MTX and MTX II Instrument Operator Manual Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Coag-A-Mate MTX and MTX II Instrument Operator Manual
Brand
Biomerieux, Inc.
Lot Codes / Batch Numbers
All Codes
Products Sold
All Codes
Biomerieux, Inc. is recalling Coag-A-Mate MTX and MTX II Instrument Operator Manual due to 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 00-9. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Consignees were notified by letter on September 29, 2003.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026