FDA Medical Device Recalls (openFDA)
Ortho-Clinical Diagnostics: VITROS 5600 Integrated System Software Version 1.6 & Below Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.
- Recall number
- Z-1699-2012
- Recalling firm
- Ortho-Clinical Diagnostics
- Product
- VITROS 5600 Integrated System Software Version 1.6 & Below Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.
- Status
- Terminated
- Initiated
- 2012-04-26
- Posted
- 2012-06-01
- Terminated
- 2018-07-05
- Reason
- Ortho Clinical Diagnostics is recalling VITROS 5600 Integrated System Software Version 1.6 and below because of an anomaly that may inadvertently add a surfactant to a CurveTip position.
- Root cause
- Software design
- Action
- Ortho Clinical Diagnostics (OCD) sent an Urgent Product Correction Notification letter dated April 26, 2012, via FedEx overnight courier to US consignees with VITROS 5600 Systems. The letter identified the affected product, problem and actions to be taken. Foreign affiliates were informed by email on April 26, 2012 of the issue and instructed to notify their consignees of the issue and actions. OCD recommend customers to group all DAT assays into a single run as described in the letter, until the next Software Version 2.0 is installed on their VITROS 5600 System. Customers were instructed to complete and return the Confirmation of Receipt form. For questions contact Customer Technical Services at 1-800-421-3311
- Quantity
- 1357 units
- Distribution
- Worldwide Distribution - US (nationwide)
- Lot, serial or model codes
- Product code: 6802413; Serial numbers: 56000118 - 56001498
- 510(k) numbers
- ["K081543"]
- PMA numbers
- not on file
- Product code
- JJE
- Firm FEI
- 1000305841
- 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