VITROS Chemistry Products VersaTips - Product Usage: used to dispense samples to MicroSlide assay...

FDA Device Recall #Z-1136-2021 — Class II — January 14, 2021

Recall Summary

Recall Number Z-1136-2021
Classification Class II — Moderate risk
Date Initiated January 14, 2021
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Ortho-Clinical Diagnostics, Inc.
Location Rochester, NY
Product Type Devices
Quantity 4,062 cartons of 1,000 tips (Totaling 4,062,000 tips)

Product Description

VITROS Chemistry Products VersaTips - Product Usage: used to dispense samples to MicroSlide assays and sample and reagent fluid for MicroWell assays. In addition, VersaTips are used to dispense R1 Reagent Fluid into cuvettes in combination with sample fluid for Micro Tips Assays.

Reason for Recall

A deformity affecting a specific lot of VITROS¿ Chemistry Products VersaTips. Deformed VersaTips results may be biased by up to +/-16% for both immunometric and competitive assays.

Distribution Pattern

Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI and the country of Canada.

Lot / Code Information

Lot 413420 Model(s): VITROS 250, VITROS 350, VITROS ECi, VITROS 5,1 FS, VITROS 3600, VITROS 4600, VITROS 5600, VITROS XT7600.

Other Recalls from Ortho-Clinical Diagnostics, Inc.

Recall # Classification Product Date
Z-2559-2025 Class II Chemistry Products LAC Slides. Catalog Number: ... Jul 29, 2025
Z-2560-2025 Class II VITROS Chemistry Products LAC Slides. Catalog N... Jul 29, 2025
Z-2335-2025 Class II VITROS Chemistry Products Ca Slides; Catalog N... Jul 9, 2025
Z-2073-2025 Class II VITROS Chemistry Products OP Reagent Gen 15. Mo... Jun 12, 2025
Z-2121-2025 Class II Brand Name: VITROS Chemistry Products Product ... Jun 10, 2025

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.