FDA Medical Device Recalls (openFDA)
Ortho-Clinical Diagnostics: VITROS Chemistry Products Calibrator Kit 16, REF 680 1700, 5x1 mL --- Ortho-Clinical Diagnostics, Rochester, NY USA -- Ortho-Clinical Diagnostics High Wycomber, UK. VITROS Chemistry Products Calibrator Kit 16 is used in conjunction with VITROS Chemistry Products FS Calibrator 1 to calibrate the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System for the quantitative measurement of rheumatoid factor (RF).
- Recall number
- Z-0714-2012
- Recalling firm
- Ortho-Clinical Diagnostics
- Product
- VITROS Chemistry Products Calibrator Kit 16, REF 680 1700, 5x1 mL --- Ortho-Clinical Diagnostics, Rochester, NY USA -- Ortho-Clinical Diagnostics High Wycomber, UK. VITROS Chemistry Products Calibrator Kit 16 is used in conjunction with VITROS Chemistry Products FS Calibrator 1 to calibrate the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System for the quantitative measurement of rheumatoid factor (RF).
- Status
- Terminated
- Initiated
- 2011-11-10
- Posted
- 2012-01-11
- Terminated
- 2018-07-02
- Reason
- Ortho Clinical Diagnostics is recalling Lot 1630 of VITROS Calibrator Kit 16 because it will not likely meet its specified 12 months of stability.
- Root cause
- Nonconforming Material/Component
- Action
- A letter was sent to customers via overnight delivery on 11/10/2011. The letter informed customers they should discontinue using and discard all remaining VITROS Calibrator Kit 16, Lot 1630; Complete and return the attached Confirmation of Receipt form upon receipt of the notification. Once the fax reply is received, the firm will begin the replacement order process; forward the notification to all departments and areas that use the VITROS Calibrator Kit 16, Lot 1630; and post the notification by each VITROS Chemistry or Integrated System in your facility that uses the VITROS Calibrator Kit 16, Lot 1630 or with VITROS user documentation.
- Quantity
- 768 kits
- Distribution
- Class II Recall: Worldwide Distribution - USA (Nationwide) and the countries of Brazil, Canada, Chile, China, Colombia, England, France, Mexico, Panama, Singapore, Spain, Venezuela.
- Lot, serial or model codes
- Lot 1630
- 510(k) numbers
- ["K041863"]
- PMA numbers
- not on file
- Product code
- DHR
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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