FDA Device

Abbott m2000sp Instrument; an automated system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list 09K14

Hazard

Abbott Molecular has received reports in which the liquid waste sensor and components in the m2000sp lower instrument cabinet overheated and/or caught fire.

What You Should Do

Remedy

Abbott Molecular sent a Field Correction Recall letter dated October 10, 2011, to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer. The customer was instructed to follow the instructions identified until further notice, and to complete the enclosed reply sheet and fax it to (847) 775-6728 at their earliest convenience to acknowledge receipt and understanding of the letter. For questions regarding this recall call 224-361-7133.

Products

Abbott m2000sp Instrument; an automated system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list 09K14
Brand
Abbott Molecular
UPC
list 09K14, all serial numbers

Units Affected

432 units