| Class 2 Device Recall Cholestech LDX MultiAnalyte Controls |  |
Date Initiated by Firm | October 06, 2010 |
Date Posted | November 22, 2010 |
Recall Status1 |
Terminated 3 on August 01, 2012 |
Recall Number | Z-0439-2011 |
Recall Event ID |
56985 |
510(K)Number | K913687 |
Product Classification |
Multi-Analyte Controls - Product Code JJY
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Product | Cholestech LDX Multi-Analyte Controls, Level 1 & 2, 1 vial set, Catalog Number 12-712.
Assayed quality control material for use with the Cholestech LDX System. |
Code Information |
Lot # MV0146 |
Recalling Firm/ Manufacturer |
Biosite Inc Dba Innovacon Inc. 9975 Summers Ridge Rd San Diego CA 92121
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For Additional Information Contact | 858-455-4808 Ext. 3015 |
Manufacturer 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. |
FDA Determined Cause 2 | Pending |
Action | 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 |
Quantity in Commerce | 3,382 kits |
Distribution | Worldwide Distribution -- USA, Australia, Canada, Great Britain, India, Italy, Mexico, Norway, Puerto Rico, South Korea, Spain, Switzerland, and Trinidad & Tobago. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = JJY
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