FDA Medical Device Recalls (openFDA)
Bayer HealthCare LLC, Diagnostics Div: 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-0911-03
- Recalling firm
- Bayer HealthCare LLC, Diagnostics Div
- 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
- 2003-06-19
- Posted
- 2003-06-21
- Terminated
- 2004-09-02
- Reason
- Analyzer will produce erroneous results due to missing grounding strap.
- Root cause
- Other
- Action
- 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.
- Quantity
- 1324
- Distribution
- United States, Australia, Canada, Colombia, France, Germany, Hong Kong, India, Japan, Korea, Mexico, Sweden, Switzerland and United Kingdom.
- Lot, serial or model codes
- serial numbers 168252 through 169574.
- 510(k) numbers
- ["K960546"]
- PMA numbers
- not on file
- Product code
- not on file
- 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