Clinitek 50 Urine Chemistry Analyzer; Product codes 6509C, 6513K, 6514C, 6515C, 6516F and 6518C. [The different product
FDA device recall Z-1051-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Bayer Healthcare LLC
- Reason for recall
- Some units may only have had 1 read head screw installed instead of the three required by the firm's specifications.
- Action taken
- Consignees were notified by recall letter on or about March 12, 2003 requesting customers to return their units for inspection and rework.
- Root cause
- Other
- Status
- Terminated
- Product code
- KQO
- Quantity affected
- 424
- Distribution
- United States, Australia, Canada, France, Germany, India, Japan, Netherlands, Poland, South Korea, Sweden, Switzerland and United Kingdom.
- Date initiated
- 2004-03-12
- Date posted
- 2004-07-20
- Date terminated
- 2004-09-14
- 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 |