FDA Medical Device Recalls (openFDA)
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).
- Recall number
- Z-1051-04
- Recalling firm
- Bayer Healthcare LLC
- Product
- 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).
- Status
- Terminated
- Initiated
- 2004-03-12
- Posted
- 2004-07-20
- Terminated
- 2004-09-14
- 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.
- Lot, serial or model codes
- Serial numbers 166837 through 168088.
- 510(k) numbers
- ["K960546"]
- PMA numbers
- not on file
- Product code
- KQO
- Firm FEI
- 1810909
- Firm city
- Elkhart
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28