Recall Z-1178-2013
Alere San Diego, Inc. · initiated March 6, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Model Number 12-807. ¿ Lot/Unit Codes: 274632, 281847 ¿ Expiration date, or Expected shelf life: 5/5/13, 6/30/13
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: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-1178-2013
- Initiated
- March 6, 2013
- Posted by FDA
- April 25, 2013
- Terminated
- March 12, 2014
- Product code
- DCK – C-Reactive Protein, Antigen, Antiserum, And Control
- Quantity
- 2333 kits
- Distribution
- USA Nationwide Distribution
- Recalling firm
- Alere San Diego, Inc., San Diego, CA