Recall Z-2211-2012 ยท LFM Enzyme Immunoassay, Digitoxin
Ortho-Clinical Diagnostics
VITROS Chemistry Products DGXN Slides --- [REF] 834 3386. Product is packaged in a box with multiple slides. The lot and expiration codes are found on the side of the package. Product Usage: Intended use: For in vitro diagnostic use only. VITROS Chemistry Products DGXN Slides quantitatively measure digoxin (DGXN) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemis
| Date | Aug 15, 2012 (initiated Jun 28, 2012) |
| Status | Terminated |
| Reason | Ortho Clinical Diagnostics revised the VITROS Chemistry Products DGXN Slides Instructions for Use (IFU) and removed heparin plasma as a recommended specimen type for VITROS DGXN Slides |
| Root cause | Process control |
| Action | Ortho Clinical Diagnostics sent an Urgent Field Safety Notice dated June 28, 2012, via US Postal Service Priority Mail to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to: Immediately discontinue using heparin plasma samples and use only serum samples when processing VITROS DGXN Slides; Notify their laboratory and medical staff of this change and forward the information if the product have been distributed outside of your facility; Replace the pages of their VITROS Instructions for Use Manual with the enclo |
| Quantity | 13338 sale units |
| Distribution | Worldwide Distribution - US (nationwide) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K942610 | KODAK EXTACHEM CLINICAL CHEMISTRY SLIDE DIGOXIN (DGXN) Eastman Kodak Company, Oct 20, 1994 |