FDA recall Z-2207-2019

Product

Assayed Bovine Multi-Sera Level 1, Model No. AL1027

Reason for recall

The firm is re-assigning the Mean of all Instruments target and range for Bile Acids (5th Generation Colorimetric) in the Assayed Bovine Multi-Sera Level 1 Control Lot 205SL.

Distribution

Domestic distribution to Arizona, Oregon, Washington, and West Virginia. Foreign distribution to Australia, Belarus, Canada, France, Germany, Ireland, Kenya, Korea, Lithuania, New Zealand, Nigeria, Oman, Russia, Singapore, South Africa, Sweden, Switzerland, Turkey, and UK.

Key facts

Status

Terminated

Initiation date

2019-06-10

Report date

2019-08-14

Termination date

2020-06-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Crumlin, N/A, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2207-2019