Beckman Coulter Access Immunoassay System Hybritech PSA Calibrators, Product Number: 37205. The Access Hybritech PSA ass

FDA device recall Z-1197-2009 · posted 2009-04-28 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc

Reason for recall

Beckman Coulter incorrectly shipped Access Hybritech PSA calibrators containing dual calibration cards (Hybritech and WHO) to some Access Hybritech PSA Customers. The WHO calibration for PSA is not currently approved in the United States.

Action taken

An "Urgent: Product Corrective Action" letter dated January 10, 2008 was issued via fax or mail to customers. The letter described the issue and instructed consignees to discontinue use and discard the affected product. Consignees were also asked to complete and return a "Fax-Back Form" via fax (1-952-368-7610) or mail to Beckman Coulter, Inc. within 10 days of receiving the notification letter. Further questions should be addressed to Beckman Coulter Customer Technical Support at 1-800-854-3633.

Root cause

Packaging process control

Status

Terminated

Product code

LTJ

Quantity affected

123 Units

Distribution

Nationwide Distribution -- Including states of AL, AZ, CA, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, NC, NY, OK, OR, PA, SC, TN, TX, VA, WI and WV.

Date initiated

2008-01-08

Date posted

2009-04-28

Date terminated

2012-03-15

Location

Brea, CA