FDA recall Z-0929-2022

Product

Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 11097536

Reason for recall

Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results.

Distribution

Global Distribution. US Nationwide.

Key facts

Status

Ongoing

Initiation date

2022-02-09

Report date

2022-04-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tarrytown, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0929-2022