Recall Z-2123-2025 ยท DIH Colorimetry, Cholinesterase
Ortho-Clinical Diagnostics, Inc.
VITROS Chemistry Products CHE Slides (Japan); Catalog Numbers: (1) 684 4074 (90 slides), (2) 684 4138 (300 slides);
| Date | Jul 17, 2025 (initiated Jun 10, 2025) |
| Status | Open, Classified |
| Reason | Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs when the PVs are used 2-7 days after reconstitution; however, the label stability claims for the PV fluids is 7 days following reconstitution. This may lead to inaccurate QC results. The use of the PVs when the QC results are outside of the customer s established ranges could result in delayed results for patients due to the need to repeat QC testing or reconstitute new PV fluids and repeat testing. It could also result in erroneous pat |
| Root cause | Under Investigation by firm |
| Action | On June 10, 2025, "IMPORTANT PRODUCT CORRECTION NOTIFICATION" letters were sent to distributors and customers. CUSTOMER LETTERS: REQUIRED ACTIONS " Monitor VITROS CHE Slides QC results to detect a drift in VITROS Performance Verifiers I and II below 2x Within-lab SD limits. If QC results are below 2x WLSD, perform QC again using freshly reconstituted vials of VITROS Performance Verifiers I and II. " Complete the enclosed Confirmation of Receipt form no later than June 18, 2025. " Save this notification with your User Documentation or post this notification near your laboratory's fluid recons |
| Quantity | 414,000 (OUS) |
| Distribution | Worldwide Distribution: US (nationwide) to states of: AZ, CA, FL, GA, IL, MD, MI, MO, MS, NY, TN, TX, VA; and OUS (International) to countries of: Australia, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapor |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.