Cholestech LDX Calibration Verification, Levels 1-4, Catalog Number 11-255. To be used for verifying the reportable rang

FDA device recall Z-0443-2011 · posted 2010-11-22 · Terminated

Recall details

Recalling firm

Biosite Inc Dba Innovacon Inc.

Reason for recall

The recall was initiated because results were being reported as being out of range. Firm is reassigning ranges for HDL cholesterol in product.

Action taken

All customers were notified and given instructions, requirements, and expectations for their role in the Correction activities using the Notice of Correction with attached Returned Verification Forms which were supplied via fax, email or direct mail beginning on October 6, 2010. Customers are to share the information provided in the Notice with their laboratory staff and retain the letter as part of their laboratory Quality System documentation. If any affected product had been further distributed to another laboratory, then a copy of the letter should be provided to them. Customers are to complete and fax the enclosed Verification Form within 10 days to confirm their receipt of the notice. Consignees with questions about the information contained in the notification were instructed to contact: Alere San Diego, Inc. 9975 Summers Ridge Road San Diego, CA 92121 U.S.A. Phone: 877 441 7440 FAX: 858 805 8457 E-mail: Response.ts@alere.com

Root cause

Pending

Status

Terminated

Product code

JJY

Quantity affected

388 kits

Distribution

Worldwide Distribution -- USA, Australia, Canada, Great Britain, India, Italy, Mexico, Norway, Puerto Rico, South Korea, Spain, Switzerland, and Trinidad & Tobago.

Date initiated

2010-10-06

Date posted

2010-11-22

Date terminated

2012-08-01

Location

San Diego, CA

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