The Alere Cholestech LDX high sensitivity C-Reactive Protein (hsCRP) Test Cassette, Model Number 12-807. Product Usage:
FDA device recall Z-1178-2013 · posted 2013-04-25 · Terminated
Recall details
- Recalling firm
- Alere San Diego, Inc.
- 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.
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- DCK
- Quantity affected
- 2333 kits
- Distribution
- USA Nationwide Distribution
- Date initiated
- 2013-03-06
- Date posted
- 2013-04-25
- Date terminated
- 2014-03-12
- Location
- San Diego, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP) (K040579) | Cholestech Corp. | 2004-06-18 |