Date Initiated by Firm | March 06, 2013 |
Date Posted | April 25, 2013 |
Recall Status1 |
Terminated 3 on March 12, 2014 |
Recall Number | Z-1178-2013 |
Recall Event ID |
64701 |
510(K)Number | K040579 |
Product Classification |
C-reactive protein, antigen, antiserum, and control - Product Code DCK
|
Product | The Alere Cholestech LDX high sensitivity C-Reactive Protein (hsCRP) Test Cassette, Model Number 12-807.
Product Usage:
Immunoassay for the determination of C-Reactive Protein (CRP). The Alere Cholestech LDX high sensitivity C-Reactive Protein (hsCRP) is an in vitro diagnostic test for the quantitative determination of C-reactive protein in whole blood or serum. |
Code Information |
Model Number 12-807. ¿ Lot/Unit Codes: 274632, 281847 ¿ Expiration date, or Expected shelf life: 5/5/13, 6/30/13 |
Recalling Firm/ Manufacturer |
Alere San Diego, Inc. 9975 Summers Ridge Rd San Diego CA 92121-2997
|
For Additional Information Contact | 858-805-2000 |
Manufacturer Reason for Recall | The Alere Cholestech LDX hsCRP
cassette (PN 12-807) may have increased imprecision relative to the performance data in the package insert,
which may cause differences in quantitative results for hsCRP compared to a reference method or
repeat testing on the same patient sample. |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | Alere sent an Urgent Medical Device Recall letter dated March 6, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to block all stock of the affected lot in their warehouses; discontinue use and discard all stock on hand, complete the provided Customer Verification form to document disposal, contact their primary consignees and advise them of the required discontinuation and disposal of the affected lot. For question call 877-308-8289. |
Quantity in Commerce | 2333 kits |
Distribution | USA Nationwide Distribution |
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 = DCK
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