GEM Check Coag CNTRL Normal APTT Whole Blood Controls Package Insert: IVD. 15/pk. 06260061600. Manufactured for: Instrum
FDA device recall Z-2107-2010 · posted 2010-07-28 · Terminated
Recall details
- Recalling firm
- International Technidyne Corporation
- Reason for recall
- Certain lots of GEM Check Coag Whole Blood Controls contain an error in the package insert where the incorrect Acceptable Performance Ranges were published.
- Action taken
- Urgent: Medical Device Correction Notices, dated July 1, 2010, were sent by Federal Express on July 8, 2010 to all first consignee end users. The letters identified the affected product and asked customers to review and follow all instructions as outlined in the ITC in the communication. The info should be shared with laboratory staff and the notification should be retained as part of the laboratory Quality System documentation. The enclosed response form should be completed and returned to ITC within 5 days.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- GGN
- Quantity affected
- 95 kits C9GC5001; 32 kits G9GC5003; 46 kits J9GC5004; 5 kits C0GC5001; Each kit contains 15 vials.
- Distribution
- Worldwide Distribution -- USA, including states of NY, TN, CA, AR, IL and TX and countries of Australia, Italy, Spain, Germany, Chile, Spain, Malta, Belgium, Austria, and Switzerland.
- Date initiated
- 2010-07-08
- Date posted
- 2010-07-28
- Date terminated
- 2010-09-23
- Location
- Piscataway, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ITC WHOLE BLOOD CONTROL NORMAL/ABNORMAL LEVEL I OR II (K944691) | International Technidyne Corp. | 1995-03-15 |