FDA recall Z-1362-2019

Product

Technopath Multichem S Plus Level 1 - Product Usage: Multichem S Plus (Assayed) is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

Reason for recall

Devices were delivered without the required dry ice.

Distribution

Distribution to Latvia.

Key facts

Status

Terminated

Initiation date

2019-04-09

Report date

2019-05-22

Termination date

2019-12-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Abbott Park, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1362-2019