FDA recall Z-1267-2018

Product

EasyCAL HbA1c Calibrator; REF 10658 Kit is packaged in a paper box containing 4 vials of 0.25ml of calibrant, one for each calibration level, and an insert sheet.

Reason for recall

Patient results determined using this calibrator lot might deviate up to 20%. Controls might not indicate false values.

Distribution

USA: MI FL CA TX India, Russia, Puerto Rico, N. Mariana Island/Palau.

Key facts

Status

Terminated

Initiation date

2017-04-11

Report date

2018-04-04

Termination date

2019-08-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bedford, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1267-2018