Recall Z-2364-2020 ยท CIW Starch-Dye Bound Polymer, Amylase
Ortho-Clinical Diagnostics
VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/300 SLDS, Product Code 1202670, UDI # 10758750008513 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems.
| Date | May 11, 2020 |
| Status | Terminated |
| Reason | Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as listed on the Performance Verifier (PV) Assay Sheets. |
| Root cause | Under Investigation by firm |
| Action | On May 11, 2020, Ortho Clinical Diagnostics, Inc. sent an Urgent Medical Device Correction Notification to their customers alerting them of important information regarding the precision of VITROS AMYL Slides. The notice stated that the imprecision affects serum, urine and QC samples, however VITROS AMYL Slides performance continues to meet its intended clinical use. The VITROS Performance Verifiers I and II Control Assay Sheet estimated within-lab SD, Range of Means (ROM) and Delta table values were re-evaluated. The Delta tables will be updated in a future revision of the Performance Verifier |
| Quantity | 73,071 |
| Distribution | Worldwide distribution - US Nationwide including in the statesof Maine, Massachusetts, Vermont, Connecticut, New Jersey, New York, Pennsylvania, Washington DC, Maryland, Virginia, West Virginia, North Carolina, South Carolina, Georgia, Florida, Alabama, Tennessee, Missouri, Mississippi, Kentucky, Oh |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K812027 | KODAK EKTACHEM CLIN. CHEM. SLIDES (AMYL) Eastman Kodak Company, Aug 3, 1981 |