FDA recall Z-0045-2020

Helena Laboratories, Corp. · Class II · device

Product

SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.

Reason for recall

The plates do not have wells punched for the controls in the patient 1 area.

Distribution

Distribution was made to IN, KY, MA, OH, OR, TN, and TX. There was government distribution. Foreign distribution was made to Chile.

Key facts

Status
Terminated
Initiation date
2017-07-21
Report date
2019-10-16
Termination date
2020-06-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Beaumont, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0045-2020