Clinitek 50 Urine Chemistry Analyzer; Product codes 6509C, 6513K, 6514C, 6515C, 6516F and 6518C. [The different product
FDA device recall Z-0911-03 · posted 2003-06-21 · Terminated
Recall details
- Recalling firm
- Bayer HealthCare LLC, Diagnostics Div
- Reason for recall
- Analyzer will produce erroneous results due to missing grounding strap.
- Action taken
- Marketing sent a 'dear customer' letter to each account on May 13, 2003 telling them that their instrument had been identified as not meeting a production specification. An urgent product correction letter was subsequently sent to each account on or about June 20, 2003. The analyzers affected will be replaced.
- Root cause
- Other
- Status
- Terminated
- Quantity affected
- 1324
- Distribution
- United States, Australia, Canada, Colombia, France, Germany, Hong Kong, India, Japan, Korea, Mexico, Sweden, Switzerland and United Kingdom.
- Date initiated
- 2003-06-19
- Date posted
- 2003-06-21
- Date terminated
- 2004-09-02
- Location
- Elkhart, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CLINITEK 50 URINE CHEMISTRY ANALYZER (K960546) | Bayer Corp. | 1996-06-12 |