Calcium Reagent Set. Pointe Scientific Liquid Hitachi Calcium Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog #
FDA device recall Z-1041-2010 · posted 2010-03-10 · Terminated
Recall details
- Recalling firm
- Pointe Scientific, Inc.
- Reason for recall
- Non-compliance with the Good Manufacturing Practice regulations, as the manufacturing process for this product had not been validated.
- Action taken
- Consignees were notified by "Urgent: Medical Device Recall" letter dated November 11, 2009 and instructed to conduct a recall to the retail level, that users should dispose of the product immediately, and that a business reply card should be returned to account for products. If you have any questions, please call Pointe Scientific, Inc. Technical Support Department at 1-800-757-5313 or 1-734-487-8300.
- Root cause
- Process control
- Status
- Terminated
- Product code
- CIC
- Quantity affected
- 44 sets
- Distribution
- Worldwide Distribution (United States, Chile, India, Republic of Yemen and Trinidad).
- Date initiated
- 2009-11-10
- Date posted
- 2010-03-10
- Date terminated
- 2010-12-10
- Location
- Canton, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PSI CALCIUM REAGENT (K822469) | Pointe Scientific, Inc., | 1982-09-14 |