Cell Marque CD7 (MRQ-12); Mouse Monoclonal Antibody, Antibody is bottle in HDPE bottle with screw cap lid with container

FDA device recall Z-1176-2012 · posted 2012-03-06 · Terminated

Recall details

Recalling firm

Cell Marque Corporation

Reason for recall

Letter received from supplier that material received in October 2009 was labeled as CD7, but was actually CD 2.

Action taken

Cell Marque sent a Field Notification letter dated January 23, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to complete and return the attached form indicating they have received the notification. Customers were also asked to destroy any existing inventory of the affected product. If the product was shipped to their customers, customers should confirm that they have contacted those customers. Customers were asked to complete, sign and date and return the attached Acknowledgement Form by faxing it to 1-916-746-8989 or by scanning it and emailing it to bdevos@cellmarque.com. For questions regarding this recall call 1-800-665-7284 or 1-916-746-8900. .

Root cause

Mixed-up of materials/components

Status

Terminated

Product code

NJT

Quantity affected

110 units

Distribution

Worldwide Distribution - USA (nationwide) and the countries of Australia, Greece, Turkey, Italy, The Netherlands, Spain, Portugal, France, Israel, S. Korea, Pakistan, Morocco, Russia and Brazil.

Date initiated

2012-01-23

Date posted

2012-03-06

Date terminated

2012-10-19

Location

Rocklin, CA