FDA recall Z-0970-2018

Product

Immunoassay Premium Plus Controls (3x4x5mL and 12x5mL packages)

Reason for recall

The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconstituted stability claim in the product IFU.

Distribution

Distribution US nationwide.

Key facts

Status

Terminated

Initiation date

2017-08-11

Report date

2018-03-21

Termination date

2019-03-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Kearneysville, WV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0970-2018