FDA recall Z-1695-2023

Product

RR Mechatronics Control Level A ESR Control4.6 ml QRR049002- In-vitro diagnostic quality control material to monitor the precision of Starrsed Erythrocyte Sedimentation Rate (ESR) instruments and procedures. Product Code: A0026578

Reason for recall

QRR049001 Lot QCAB6AN505 incorrectly labelled as QRR049002 Lot QCAB6AAA28. The incorrectly labelled vial will upload the range for the Starrsed Control Level A and the instrument result will be flagged as out of range.

Distribution

Worldwide distribution - US Nationwide distribution in the state of OH and the country of Netherlands.

Key facts

Status

Ongoing

Initiation date

2023-04-14

Report date

2023-06-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warwick, RI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1695-2023