AIA-PACK TPOAb CONTROL SET
FDA device recall Z-2168-2017 · posted 2017-05-15 · Terminated
Recall details
- Recalling firm
- Tosoh Bioscience, Inc.
- Reason for recall
- The label contains two different methodologies. Quality Control values for non-FDA approved methodology (CL) are on the label in addition to the FDA approved methodology values (AIA). Two sets of instructions were included on the label.
- Action taken
- On 3/3/2017 the firm sent recall notificaion letters to their customers.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- JZO
- Quantity affected
- 15 boxes
- Distribution
- Product was shipped to the following states: AK, FL, GA, MA, NY, NY, OH, OK & TX.
- Date initiated
- 2017-02-08
- Date posted
- 2017-05-15
- Date terminated
- 2019-02-08
- Location
- South San Francisco, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AIA-PACK TPOAB ASSAY (K981521) | Tosoh Medics, Inc. | 1998-10-08 |