Recall Z-1072-2012 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Ortho-Clinical Diagnostics
VITROS 3600 Immunodiagnostics Systems, Catalog # 6802783; COMMON/USUAL NAME: VITROS 3600 --- NOTE: VITROS 3600 that are e-Connected are not affected by this issue. Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents.
| Date | Feb 21, 2012 (initiated Apr 13, 2011) |
| Status | Terminated |
| Reason | Ortho Clinical Diagnostics (OCD) received customer complaints regarding the loss of calibration data following the installation of a development Assay Data Disk (ADD) that was available in the on-screen mailbox on the Main Menu System Status screen of their VITROS 5600 Integrated System. OCD's investigation determined that ADD, Data Release Version (DRV) 9241 or 9251 was electronically transferr |
| Root cause | Software design |
| Action | Ortho-Clinical Diagnostics (OCD) sent an Important Product Correction Notification letters dated April 13, 2011 via FedEx overnight to customers with an affected VITROS 3600 or 5600 System (those not e-Connected). Foreign affiliate consignees were informed of this action via e-mail on April 13, 2011. The letters described the affected products, problem and actions to be followed. The letters states that an OCD Field Engineer will contact customers who has the affected products and perform a Modification (MOD) procedure that will remove ADD DRV 9241 or 9251 from the on-screen mailbox of thei |
| Quantity | Domestic - 15 units, foreign - 81 units |
| Distribution | Worldwide Distribution - USA (nationwide) including the countries of: Brazil, Canada, Chile, China, England, France, Germany, India, Italy, Japan, Mexico, Singapore, Spain and Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083173 | VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 3600 IMMUNODIAGNOSTIC SYSTEM Ortho-Clinical Diagnostics, Dec 22, 2008 |