RecallRadar

FDA Device recall Z-2879-2020

VITROS XT7600 Integrated System, Product code 6844461

On 2020-09-02 the FDA classified a Class II recall of VITROS XT7600 Integrated System, Product code 6844461 by Ortho Clinical Diagnostics, citing when processing MicroSlides, slides that utilize Slot 18 in the CM rotor may be mis-positioned. As a result, certain VITROS MicroSlides may produce erroneous results.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2879-2020
ClassificationClass II
Statusterminated
Initiated2020-07-20
Published2020-09-02
Last updated2026-09-13 11:55 UTC
CompanyOrtho Clinical Diagnostics
DistributionUS

Product

VITROS XT7600 Integrated System, Product code 6844461

Reason

When processing MicroSlides, slides that utilize Slot 18 in the CM rotor may be mis-positioned. As a result, certain VITROS MicroSlides may produce erroneous results.

Identifiers

code_infoSerial numbers J76000050 - 76000566

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2879-2020%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.