FDA recall Z-2609-2023

Product

Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215

Reason for recall

there has been a transcription error in the Instructions for Use (IFU) for the Liquid Assayed Chemistry Control Premium Plus Level 3. For Caeruloplasmin, the one and two standard deviation values printed on the sheet are incorrect, which may lead to misreporting patient results. Target and range values are correct, and risk is mitigated; most clinical labs will use the target and range values in clinical practice.

Distribution

US States: GA, OH, OR, PA, TX, VA

Key facts

Status

Ongoing

Initiation date

2023-08-03

Report date

2023-09-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Crumlin (North), Ireland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2609-2023