Recalls / —
—#106485
Product
VITROS Chemistry Products Calibrator Kit 24, Catalog No. 680 1708. Common/Usual Name: VITROS Calibrator Kit 24. For in vitro diagnostics use only. VITROS Chemistry Products Calibrator Kit 24 is used 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 albumin in urine. Ortho-Clinical Diagnostics Inc.
- FDA product code
- JIT — Calibrator, Secondary
- Device class
- Class 2
- Medical specialty
- Clinical Chemistry
- 510(k) numbers
- K042643
- Affected lot / code info
- Kit Lot 2430 (exp. 11/16/11), Kit Lot 2440 (exp. 01/08/12), Kit Lot 2450 (03/09/12), Kit Lot 2471 (exp. 7/14/12)
Why it was recalled
Ortho Clinical Diagnostics received numerous complaints of lower than expected results for control fluids and patient samples upon initial calibration or following a recalibration using VITROS Chemistry Products Calibrator Kit 24 and VITROS Chemistry Products mALB Reagent.
Root cause (FDA determination)
Nonconforming Material/Component
Action the firm took
All consignees were sent "Important Product Correction Notification" communications (dated 10/27/11) beginning on 10/27/11 informing them of the issue, and instructing them to discontinue use of their remaining inventory of VITROS Chemistry Products Calibrator Kit 24, VITROS Chemistry Products mALB reagent, and VITROS Chemistry Products mALB Performance Verifiers. For questions, please contact OCD's Customer Technical Services at 1-800-421-3311.
Recalling firm
- Firm
- Ortho-Clinical Diagnostics
- Address
- 100 Indigo Creek Drive, Rochester, New York 14626
Distribution
- Distribution pattern
- Worldwide Distribution - USA, including Puerto Rico, and the countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.
Timeline
- Recall initiated
- 2011-10-27
- Posted by FDA
- 2012-02-07
- Terminated
- 2016-02-12
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #106485. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.