Recall Z-1220-2024 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Ortho-Clinical Diagnostics, Inc.
VITROS 3600 Immunodiagnostic System (New and Refurbished)
| Date | Mar 1, 2024 (initiated Jan 22, 2024) |
| Status | Open, Classified |
| Reason | Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS 3600 Immunodiagnostic Systems and VITROS 5600/XT 7600 Integrated Systems which may lead to erroneous test results. |
| Root cause | Component change control |
| Action | An URGENT PRODUCT CORRECTION NOTIFICATION letter dated 01/22/24 was sent to customers. REQUIRED ACTIONS: To reduce the risk of unintended sample aspiration, refer to the procedure provided in this notification titled, Temporary TRAY Loading Instructions . QuidelOrtho recognizes that the Temporary TRAY Loading Instructions procedure may not be tenable for all laboratories due to testing volumes. Review your laboratory risk management plan(s) to assess the need for this further mitigation. Acknowledge your understanding of this notification by completing the enclosed Confirmation of Rece |
| Quantity | 489 units (46 US, 443 OUS) |
| Distribution | Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Spain, Sweden, United Kingdom. |
| 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 |