AutoHDL Cholesterol R1 Reagent Set, a homogeneous method for the direct determination of high density lipoprotein (HDL)
FDA device recall Z-1456-06 · posted 2006-08-30 · Terminated
Recall details
- Recalling firm
- Pointe Scientific, Inc.
- Reason for recall
- Unexpected changes in QC and proficiency results due to QC and proficiency material matrix.
- Action taken
- Consignees were notified via recall letter dated 6/12/06 to cease using the product, conduct a recall to the user level, destroy product on hand and to notify the firm via the response form of the amount destroyed for replacement purposes. International accounts were notified via email.
- Root cause
- Other
- Status
- Terminated
- Product code
- CCH
- Quantity affected
- To be determined
- Distribution
- Worldwide-USA and Greece, India, Korea, Lebanon, Pakistan, Poland, Singapore, Trinidad, Turkey, United Arab Emirates and Venezuela.
- Date initiated
- 2006-06-12
- Date posted
- 2006-08-30
- Date terminated
- 2007-11-19
- Location
- Canton, MI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AUTOHDL CHOLESTEROL REAGENT SET (K992002) | Pointe Scientific, Inc., | 1999-08-05 |