ClearanceBrief
Recall Z-0136-04 ยท MAQ Kit, Dna Detection, Human Papillomavirus

Beckman Coulter Inc

Coulter DNA Prep Reagents Kit Part 6607055

DateNov 19, 2003 (initiated Oct 10, 2003)
StatusTerminated
ReasonLabeling Error-Omission of 'Research Use Only'
Root causeOther
ActionAll customers are to be notified with a product correction action letter.
Quantity284
DistributionNationwide and Canada
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.