Recall Z-1051-04 ยท KQO Automated Urinalysis System
Bayer Healthcare LLC
Clinitek 50 Urine Chemistry Analyzer; Product codes 6509C, 6513K, 6514C, 6515C, 6516F and 6518C. [The different product codes are for the various countries where the product is distributed).
| Date | Jul 20, 2004 (initiated Mar 12, 2004) |
| Status | Terminated |
| Reason | Some units may only have had 1 read head screw installed instead of the three required by the firm's specifications. |
| Root cause | Other |
| Action | Consignees were notified by recall letter on or about March 12, 2003 requesting customers to return their units for inspection and rework. |
| Quantity | 424 |
| Distribution | United States, Australia, Canada, France, Germany, India, Japan, Netherlands, Poland, South Korea, Sweden, Switzerland and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K960546 | CLINITEK 50 URINE CHEMISTRY ANALYZER Bayer Corp., Jun 12, 1996 |