FDA recall Z-0581-2020

Product

Atellica CH 930 Analyzer

Reason for recall

Potential for calibration error resulting in QC failures after the calibration run with QC and patient results being 5 times higher.

Distribution

Distributed to accounts located in AL AZ AR CA CO FL GA IL IN IA KS KY LA MA MI MN MS NE NV NH NJ NM NY NC OH OR PA SC TN TX UT WA WV DC PR. Foreign distribution to AR AU AT BS BD BE BR BG CA CL CO CW CZ DK EG FI FR DE GR HU IN IR IE IL IT JP KW LV MY MX NL NG NO CN PK PH PL PT QA KR RO RU SA SG SK ZA ES SE CH TW TH TR AE GB UY VN.

Key facts

Status

Terminated

Initiation date

2019-09-23

Report date

2019-12-04

Termination date

2022-07-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tarrytown, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0581-2020