Pointe Scientific autoHDL Reagent H7545 H7545-R1 in a bulk cube container or HDPE plastic bottle H7545-1000 kit includes
FDA device recall Z-2764-2015 · posted 2015-09-14 · Terminated
Recall details
- Recalling firm
- Pointe Scientific, Inc.
- Reason for recall
- Crystals may be observed in the R1 reagent. Crystals may be a result of the reagent being frozen during transport. The crystals do not impact product performance.
- Action taken
- Pointe Scientific sent a Field Correction Notice on March 13, 2015, to all affected customers via fax, email, and mail. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Any questions concerning the corrective action may be directed to Technical Service Department at 1-800-757-5313.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LBR
- Quantity affected
- H7545-R1, 8.75 L; 12-H7545-162, 4 kits; H7545-1000, 3 kits; HDL600, 6 kits
- Distribution
- Worldwide Distribution - US including MI, FL, CA, TX, CT, PR and Internationally to Canada.
- Date initiated
- 2015-03-13
- Date posted
- 2015-09-14
- Date terminated
- 2015-10-29
- 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 |