FDA Device

Chlamydia OIA. For in vitro diagnostic use,

Hazard

Chlamydia IVD test kits may contain diluted conjugate reagent. Use may produce a false negative result with a low positive patient sample.

What You Should Do

Remedy

All consignees were notified by telephone on 2/6/2003, followed by letter on 2/10/2003.

Products

Chlamydia OIA. For in vitro diagnostic use,
Brand
Thermo Biostar, Incorporated
UPC
Catalog No. CHL30, Lot No. 132117, 132117A,133101

Units Affected

286 units