VITROS Chemistry Products VersaTips — Class II medical device recall Z-1136-2021
Terminated recall by Ortho-Clinical Diagnostics, Inc., reported 2021-03-03, distributed nationwide. A deformity affecting a specific lot of VITROS¿ Chemistry Products VersaTips. Deformed VersaTips results may b
| Recall number | Z-1136-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, Inc., Rochester, NY, United States |
| Recall initiated | 2021-01-14 |
| Classified | 2021-02-19 |
| Reported by FDA | 2021-03-03 |
| Terminated | 2022-12-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Lot numbers | 413420 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1136-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.