FDA Medical Device Recalls (openFDA)
Ortho-Clinical Diagnostics: VITROS 4600 Chemistry System, Product Code/Catalog Number 6802445 for in vitro diagnostic use.
- Recall number
- Z-1734-2014
- Recalling firm
- Ortho-Clinical Diagnostics
- Product
- VITROS 4600 Chemistry System, Product Code/Catalog Number 6802445 for in vitro diagnostic use.
- Status
- Terminated
- Initiated
- 2014-04-10
- Posted
- 2014-06-09
- Terminated
- 2018-05-21
- Reason
- Potential for biased results when a Multiple Window (MW) code is associated with results generated by the VITROS 4600 Chemistry System, the VITROS 5600 Integrated System and the VITROS 5,1 Chemistry System. MW codes may be associated with results from any of the following VITROS Chemistry Products using multiple point (multipoint) rate measurements. The MicroSlide assays that could be affected
- Root cause
- Software design
- Action
- Important Product Correction Letters (CL2014-116, dated 4/10/2014) were sent on 4/10/2014 via FedEx overnight courier or ORTHO PLUS e-Communications to all customers with VITROS 5,1 FS, 5,1 FS Refurbished, 4600,and/or 5600 Systems. They were informed of the issue and advised to: -- Review VITROS ALT, ALTJ, ALKP, ALKPJ, AST, ASTJ, CHE, CHEJ, CK, CKJ, GGT, GGTJ, LDH and LDHJ results generated on VITROS 4600/5600 and 5,1 FS Systems. Do not report any results associated with an MW code. -- Perform repeat testing in singlicate on all samples with results having an MW code. Only results without an MW code are acceptable. -- Review their current Laboratory Information System (LIS) configuration to determine if changes are required in order to restrict reporting of results with an MW code. Customers with questions should contact Customer Technical Services at 1-800-421-3311. --- Foreign affiliates were informed of the issue by e-mail on 4/10/2014 and instructed to notify their consignees of the issue and actions.
- Quantity
- Domestic - 82, Foreign - 213 units
- Distribution
- Worldwide distribution including US Nationwide, Puerto Rico, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.
- Lot, serial or model codes
- Software Version 3.0 and lower; Serial Numbers J46000108 through J46000403
- 510(k) numbers
- ["K031924"]
- 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
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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