CoaguChek Plus meter; catalog # 475729 and 12816001.
FDA device recall Z-0814-03 · posted 2003-05-14 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- Reason for recall
- High frequency signals from other medical or communications equipment will result in a variable positive bias in test results.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JPA
- Quantity affected
- 472
- Distribution
- United States
- Date initiated
- 2003-03-12
- Date posted
- 2003-05-14
- Date terminated
- 2005-02-03
- Location
- Indianapolis, IN
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| BIOTRACK PROTIME CONTROLS (BIOTRACK PROTIME TEST) (K860719) | Biotrack, Inc. | 1986-05-23 |