FDA Device recall Z-1136-2021
VITROS Chemistry Products VersaTips - Product Usage: used to dispense samples to MicroSlide assays and sample and reagent fluid for MicroWe…
- FDA Device
- Class II
- terminated
- Published 2021-03-03
On 2021-03-03 the FDA classified a Class II recall of VITROS Chemistry Products VersaTips - Product Usage: used to dispense samples to MicroSlide assays and sample and reagent fluid for MicroWe… by Ortho Clinical Diagnostics, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1136-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-01-14 |
| Published | 2021-03-03 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
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
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.
Identifiers
| code_info | Lot 413420 Model(s): VITROS 250, VITROS 350, VITROS ECi, VITROS 5,1 FS, VITROS 3600, VITROS 4600, VITROS 5600, VITROS XT7600. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1136-2021%22
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