CoaguChek Pro DM meter; catalog # 1894048 and 1893211.
This recall has been terminated (originally issued May 14, 2003).
- Company
- Roche Diagnostics Corp.
- Recall Initiated
- March 12, 2003
- Posted
- May 14, 2003
- Terminated
- February 3, 2005
- Recall Number
- Z-0813-03
- Quantity
- 1322
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
Reason for Recall
High frequency signals from other medical or communications equipment will result in a variable positive bias in test results.
Distribution
United States
Lot / Code Info
All units.
Root Cause
Other
Action Taken
Urgent Product Removal letters dated 3/12/03 were sent to all customers. Distributors were asked to conduct a recall from their customers. Replacement meters are not currently available from Roche. Roche will temporarily provide a CoaguChek S system to run PT samples and will reimburse for APTT and ACT tests that are sent to an accredited outside laboratory.
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