VACUETTE Cellestis 1 ml QuantiFERON - TB ANTIGEN; Shake 10x; REF 454074; HE0105; 13X75 50 pcs.,1200 pcs. in total; Produ

FDA device recall Z-0888-2013 · posted 2013-02-26 · Terminated

Recall details

Recalling firm

Cellestis Inc

Reason for recall

Cellestis is recalling QuantiFERON - TB Gold TB Blood Collection Tubes and HA TB Blood Collection Tubes due to potential contamination.

Action taken

Cellestis, inc., sent a "Notification of market withdrawal of QuantiFERON" letter dated September 27, 2012 to its domestic and international customers. The letter described the product, problem and actions to be taken. The customers were informed to discontinue use of these products and any product sequestered such that it cannot be used or distributed. Cellestis will provide replacement materials, if and when a retest is required. Please do not hesitate to contact your local QuantiFERON sales representative or customer service representative at +613 8527 3500 or 661-775-7480 should you have any questions or concerns.

Root cause

Process design

Status

Terminated

Product code

NCD

Quantity affected

309,400 units

Distribution

Worldwide distribution: USA (nationwide) and countries of: Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Germany, Great B

Date initiated

2012-09-27

Date posted

2013-02-26

Date terminated

2013-04-25

Location

Santa Clarita, CA