Terminated

CO2 Incubators (General Purpose Incubator), model numbers 370, 371, 380, 381, 3307, 3308, 3310, 3311, 3540, 3541, 3542, 3543, 3584, 3585, 3598, and 3599. Product Usage: Incubators are designed to maintain an optimal environment for the incubation of tissue and cell samples. These models are designed to maintain temperature, carbon dioxide, and humidity levels.

FDA Recall Z-1079-2013 · Posted 2013-04-10

Recalling FirmThermo Fisher Scientific (Asheville) LLC

Recall StatusTerminated

Product CodeJTQ

Date Initiated2012-11-29

Date Terminated2015-04-14

Product Quantity15,567 incubators

Reason for Recall

Incubators manufactured prior to mid 2009 have coated metal hinges that have reportedly failed in the field.

Firm Action

Thermo Fisher sent an Urgent Field Correction Notice letter dated November 19, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to locate all affected products and determine if it is within the recall. If so, they are to return the Acknowledgement Form in order to get replacement hinges and instructions. Upon receipt of the new hinges they are to replace them according to the instructions.

Root Cause

Component design/selection

Distribution Pattern

Worldwide Distribution - USA (nationwide) including the states of: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SN, TN, TX, UT, VA, VT, WA, WI, WV & WY. and the countries: AFGHANISTAN, ARGENTINA, AUSTRALIA, AUSTRIA, BELARUS, BELGIUM, BRAZIL, CANADA, CHILE, COSTA RICA, DENMARK, EGYPT, ENGLAND, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, ICELAND, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KOREA, LEBANON, MALAYSIA, MEXICO, NEPAL, NETHERLANDS, NEW ZEALAND, NORWAY, PALESTINE, PEOPLES REPUBLIC OF CHINA, PERU, PHILIPPINES, PORTUGAL, QATAR, REPUBLIC OF PANAMA, ROMANIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, VENEZUELA, VIETNAM & WEST INDIES.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.