Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set Model Number(s): L7572. For the in vitro quantitative kinet
FDA device recall Z-2165-2017 · posted 2017-05-26 · Terminated
Recall details
- Recalling firm
- Medtest Holdings, Inc.
- Reason for recall
- Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set stability claim is not being met.
- Action taken
- Pointe Scientific issued field communication alerting end users of the corrected stability claim. To date the firm has sent individualized communications to 100% of end users that received the product and posted the notification to the company website.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- CFJ
- Quantity affected
- 716.146L total
- Distribution
- Nationwide
- Date initiated
- 2011-07-08
- Date posted
- 2017-05-26
- Date terminated
- 2017-06-02
- Location
- Canton, MI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LIQUID LDH-L REAGENT SET (K973589) | Pointe Scientific, Inc., | 1997-10-08 |