MagNA Pure LC Instrument; catalog numbers 2236931 and 03670325001.
FDA device recall Z-0297-05 · posted 2004-12-08 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- Reason for recall
- Test results may be adversely affected by software shutting down the cooling blocks in systems with software version 3.09.
- Action taken
- Consignees were notified via letter dated 11/5/04, which provides the user with a workaround.
- Root cause
- Other
- Status
- Terminated
- Product code
- NPQ
- Quantity affected
- 65
- Distribution
- Nationwide.
- Date initiated
- 2004-11-05
- Date posted
- 2004-12-08
- Date terminated
- 2005-08-29
- Location
- Indianapolis, IN
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