Remel Xpect Clostridium difficile Toxin A/B, IVD, 20 clostridium difficile toxin A/B tests, REF 24650. Product Usage: Us

FDA device recall Z-0806-2013 · posted 2013-02-12 · Terminated

Recall details

Recalling firm

Remel Inc

Reason for recall

The firm is recalling the products due to a potential for false negative test results.

Action taken

Thermo Fisher sent a recall notification letter with details of the recall on August 20, 2012 to all affected customers. The letter identified the affected products, problem and actions to be taken. Customers were requested to follow the instructions provided and fax back the attached "Acknowledgement & Receipt Form" to 1-877-428-1924 (toll free in the US) or 1-913-895-4190 (International). For questions contact the Technical Services Department at 800-255-6730 (US) or 913-888-0939 (International).

Root cause

Material/Component Contamination

Status

Terminated

Product code

LLH

Quantity affected

493 of lot 082505; 529 of lot 131988; and 448 of lot 131994

Distribution

Worldwide Distribution - USA Nationwide and the countries Canada and the United Kingdom

Date initiated

2012-08-20

Date posted

2013-02-12

Date terminated

2013-06-04

Location

Lenexa, KS