Recall Z-0008-2024 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Ortho-Clinical Diagnostics, Inc.
Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Chemistry System (Refurbished) (Product Code 6801890), VITROS 3600 Immunodiagnostic System (Product Code 6802783), VITROS 3600 Immunodiagnostic System (Refurbished) (Product Code 6802914), VITROS 4600 Chemistry System (Product Code 6802445), VITROS 4600 Chemistry System (Refurbished
| Date | Oct 2, 2023 (initiated Aug 9, 2023) |
| Status | Open, Classified |
| Reason | Ortho Clinical Diagnostics (QuidelOrtho) confirmed certain Proboscis/Piston Assemblies manufactured between 07-Apr-2022 (Date code: 040722) and 19-Dec-2022 (Date code: 121922) may not perform as intended due to an out-of-specification barrel component. This may cause VITROS VersaTips and/or VITROS MicroTips to be improperly seated on the proboscis, which may result in falsely elevated Gentamicin and Valproic Acid assay results as well as an increased frequency of condition codes resulting in delayed patient results. The issue was identified by internal testing when reported instruments failed |
| Root cause | Under Investigation by firm |
| Action | An URGENT PRODUCT CORRECTION NOTIFICATION dated 8/9/23 was sent to customers. To determine if your laboratory is using an Assembly that was manufactured within the affected date range, check the date code stamped into the barrel of the Assembly. Refer to the example image below to locate the date code on the barrel component of the Assembly. If your laboratory has an Assembly with a date code between 040722 - 121922, the Assembly is considered affected and must be replaced. REQUIRED ACTION " Determine if any of the impacted VITROS Systems in your laboratory are using an affected Proboscis/Pi |
| Quantity | 9,860 assemblies |
| Distribution | Worldwide - US Nationwide distribution. |
| 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 |
| K081543 | VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEM Ortho-Clinical Diagnostics, Inc., Oct 23, 2008 |
| K083173 | VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 3600 IMMUNODIAGNOSTIC SYSTEM Ortho-Clinical Diagnostics, Dec 22, 2008 |
| K182063 | VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VIT Ortho-Clinical Diagnostics, Inc., Oct 30, 2018 |