Roche Diagnostics Corp. CoaguChek Plus meter; catalog # 475729 and 12816001. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CoaguChek Plus meter; catalog # 475729 and 12816001.
Brand
Roche Diagnostics Corp.
Lot Codes / Batch Numbers
All units
Products Sold
All units
Roche Diagnostics Corp. is recalling CoaguChek Plus meter; catalog # 475729 and 12816001. due to High frequency signals from other medical or communications equipment will result in a variable positive bias in test results.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
High frequency signals from other medical or communications equipment will result in a variable positive bias in test results.
Recommended Action
Per FDA guidance
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.
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