Recall Z-0848-2015 ยท CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
Ortho-Clinical Diagnostics
VITROS CHEMISTRY PRODUCTS TRIG Slides, REF 133 6544, IVD For in vitro diagnostic use only. VITROS Chemistry Products TRIG Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
| Date | Dec 22, 2014 (initiated Nov 6, 2014) |
| Status | Terminated |
| Reason | Potential for biased results using the specific lot of VITROS CHEMISTRY PRODUCTS TRIG slides. |
| Root cause | Nonconforming Material/Component |
| Action | Ortho Clinical Diagnostics sent an Urgent Product Correction Notification dated November 6, 2014, via FedEx overnight courierand/or ORTHO PLUS e-Communications and/or US Postal Service Priority Mail (for PO Boxes only) to all affected customers. The letter identified the product, the problem, and the acton to be taken by the customer. The letter informed the customers of the issue and advise them to discontinue use of the affected lot and to inform their Laboratory Medical Director if they suspect that a previously reported result may have been affected. For additional questions, please con |
| Quantity | USA: 380 units, Foreign: 155 units |
| Distribution | Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain and Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K812029 | KODAK EKTACHEM CLIN. CHEM. SLIDES (TRIG) Eastman Kodak Company, Aug 3, 1981 |