Haemonetics TEG Hemostasis System Level II Control, Catalog number: 8002. Level II Control is a biological control for u
FDA device recall Z-1130-2015 · posted 2015-02-19 · Terminated
Recall details
- Recalling firm
- Haemonetics Corporation
- Reason for recall
- Specific lots of Level II Control Kits produce high Maximum Amplitude (MA) results, which are outside of the manufacturer's expected Quality Control range for MA parameter.
- Action taken
- Haemonetics issued on 1/26/15, an Urgent Medical Device Recall to consignees The letter identified the affected product, the reason for the recall, as well as the risk to health. It instructs consignees to inspect their stock and determine if they have any of the affected lots. Customers are to immediately discontinue use and discard as instructed any affected product. The attached customer acknowledgment form should be completed and returned whether or not customers have any affected product. Customers are to contact their local service representative at 1-800-537-2802 if replacement product is needed. If any affected product has been forwarded to other locations, customers are to inform them of the recall. Please call the Technical Support team at 1-800-438-2834, with questions about this action.
- Root cause
- Process control
- Status
- Terminated
- Product code
- JPA
- Quantity affected
- 4,143 kits
- Distribution
- Worldwide Distribution -- US, Canada, Czech Republic, Denmark, Great Britain, and Sweden.
- Date initiated
- 2015-01-26
- Date posted
- 2015-02-19
- Date terminated
- 2015-06-05
- Location
- Braintree, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES (K002177) | Haemoscope Corp. | 2000-09-14 |