ClearanceBrief
Recall Z-0874-05 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone

Nichols Institute Diagnostics

Nichols Advantage TSH - Third Generation

DateApr 28, 2005
StatusTerminated
ReasonDoes not meet performance claims in the labeling.
Root causeOther
ActionFirm sent recall letter and response form April 28, 2005. Firm will follow-up to nonrespondants.
Quantity1072
DistributionNationwide, Germany, Greece and Spain
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.