Recall Z-1503-2021 ยท PCL Enzyme Linked Immunoabsorbent Assay, Rubeola Igm
Clark Laboratories, Inc.
Trinity Biotech Captia Measles IgM Kit, Catalog No. 2326060 - Product Usage: intended for the qualitative detection of Measles igM antibodies in human serum of patients suspected of measles (rubeola) infection.
| Date | Mar 17, 2021 |
| Status | Terminated |
| Reason | Positive Control may run high out of its assigned ISR range and result in an invalid run and necessitate retesting |
| Root cause | Under Investigation by firm |
| Action | Trinity Biotech issued Product Notification Letter on March 17, 2021 stating reason for recall, health risk and action to take: Please note, if a laboratorys test resulted in a valid run, such as all kit Controls and Calibrator met the Quality Control Criteria as stated in the package insert, the patient results can be reported and a re-evaluation of patient results is not necessary. Customers are instructed to discontinue the use of any Measles IgM Lot #2326060-060 kits that they may have in their inventory. Please complete the attached fax back form informing us of how many of these kits you |
| Quantity | 80 kits |
| Distribution | Worldwide distribution - US Nationwide distribution and the country of Ireland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140455 | CAPTIA MEASLES IGM Trinity Biotech USA, May 22, 2014 |