FDA Medical Device Recalls (openFDA)
Ortho-Clinical Diagnostics: VITROS 4600 Chemistry System, Software Version 3.2 & Below. Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use.
- Recall number
- Z-1742-2015
- Recalling firm
- Ortho-Clinical Diagnostics
- Product
- VITROS 4600 Chemistry System, Software Version 3.2 & Below. Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use.
- Status
- Terminated
- Initiated
- 2015-04-06
- Posted
- 2015-06-09
- Terminated
- 2018-05-25
- Reason
- Software anomaly allows testing of multiple assays using a single urine specimen, regardless of the pretreatment requirements for each selected assay, potentially leading to biased patient results.
- Root cause
- Software design
- Action
- On April 6, 2015, Ortho Clinical Diagnostics distributed correction notification letters and response forms to their customers via courier service. All urine patient results that require pretreatment was advised to refer to the notice of correction for instructions. Correction notices should also be posted beside the device user documentation for easy reference. Customers were advised to complete and return the Confirmation of Receipt before April 20, 2015. Customers with questions may contact the Customer Technical Service at 1-800-421-3311 anytime..***CAPA***Since the Assay Data Disk (ADD) provides data tables that determine which assays can be tested from the same sample container, an updated ADD is being created to address the anomaly on the VITROS 4600 and 5600. The anomaly will be addressed with an updated ADD is uploaded and the revised ADD mitigates the issue totally. Anticipated date of availability TBD.
- Quantity
- 255 units total (131 domestically & 255 internationally)
- Distribution
- Worldwide Distribution-US (nationwide), Brazil, Chile, Mexico, Australia, Hong Kong, India, Taiwan, Belgium, Denmark, France, Ireland, Italy, Portugal, Romania, Spain, Sweden and the UK.
- Lot, serial or model codes
- Product Code: 6802445 Unique Device Identifier No.: 10758750012343
- 510(k) numbers
- ["K081543"]
- PMA numbers
- not on file
- Product code
- JJE
- Firm FEI
- 1000136573
- Firm city
- Rochester
- Firm state
- NY
- 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