Recall Z-0714-2012
Ortho-Clinical Diagnostics · initiated November 10, 2011
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).
Codes / lots: Lot 1630
Reason for recall
Ortho Clinical Diagnostics is recalling Lot 1630 of VITROS Calibrator Kit 16 because it will not likely meet its specified 12 months of stability.
FDA-determined cause: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-0714-2012
- Initiated
- November 10, 2011
- Posted by FDA
- January 11, 2012
- Terminated
- July 2, 2018
- Product code
- DHR – System, Test, Rheumatoid Factor
- 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.
- Recalling firm
- Ortho-Clinical Diagnostics, Rochester, NY