Recall Z-2040-2025 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Ortho-Clinical Diagnostics, Inc.
Brand Name: VITROS Product Name: VITROS 4600 Chemistry System Model/Catalog Number: (1) 6802445, (2) 6900440 Software Version: version 3.2 to version 3.8.3 (all available software versions) Product Description: In vitro diagnostic chemistry analyzer.
| Date | Jun 27, 2025 (initiated May 9, 2025) |
| Status | Open, Classified |
| Reason | a software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the Use Expired Reagents setting is not enabled if a shelf expiration date is omitted during manual loading. The issue was identified by a customer complaint, in which a CREA Urine test was processed with an RE (Reagent Expired) code, even though the diluent pack was not expired and the use-expired-reagents setting was disabled. This can result in erroneous test results and/or delaying test results. |
| Root cause | Software design |
| Action | On May 22, 2025, "URGENT PRODUCT CORRECTION NOTIFICATION" letters were sent to customers. REQUIRED ACTIONS - To prevent this issue from occurring, the shelf expiration date must be entered when manually loading VITROS Diluent Packs on VITROS 4600/5600/XT 7600 Systems. - View the Reagent Management Supply 3 screen to check for any onboard VITROS Diluent Packs marked as expired. o For all VITROS Diluent Packs marked as expired, navigate to View By Reagent View Dil/ANC and confirm the shelf expiration date matches the shelf expiration date on the product labeling. o If the shelf expiration date |
| Quantity | 1262 units (135 US, 1127 OUS) |
| Distribution | Worldwide Distribution: US (Nationwide) and OUS (International) to 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
| K031924 | VITROS 5,1 FS CHEMISTRY SYSTEM, VITROS CHEMISTRY PRODUCTS DHDL REAGENT PACK, CALIBRATOR KIT 19, FS CALIBRATOR 1 Ortho-Clinical Diagnostics, Aug 7, 2003 |