VITROS Chemistry Products Calibrator Kit 24, Catalog No. 680 1708. Common/Usual Name: VITROS Calibrator Kit 24. For in v
FDA device recall Z-0971-2012 · posted 2012-02-07 · Terminated
Recall details
- Recalling firm
- Ortho-Clinical Diagnostics
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JIT
- Quantity affected
- 4436 units worldwide (domestic - 2201; foreign - 2235)
- Distribution
- 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, Sin
- Date initiated
- 2011-10-27
- Date posted
- 2012-02-07
- Date terminated
- 2016-02-12
- Location
- Rochester, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VITROS CHEMISTRY PRODUCT MALB REAGENT, CALIBRATOR KIT 24, MALB PERFORMANCE VERIFIERS I AND II (K042643) | Ortho-Clinical Diagnostics, Inc. | 2004-11-18 |