MAS Urinalysis Control Level 1, Multi-analyte control (Assayed and Unassayed), Catalog/Part Numbers: 024222; Product is
FDA device recall Z-0383-2014 · posted 2013-11-22 · Terminated
Recall details
- Recalling firm
- Thermofisher Scientive
- Reason for recall
- Via one (1) consumer complaint and in-house testing has confirmed that the product does not meet the 30 day open vial stability specifications for Lot: UA1514011.
- Action taken
- ThermoFisher Scientific, sent an Urgent Medical Device Field Correction letter dated October 29, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use, segregate and discard the affected product. Customers with questions were instructed to contact mas.controls@thermofisher.com. For question regarding this recall call 1-800-232-3342.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- JJW
- Quantity affected
- 914 units
- Distribution
- Worldwide Distribution - USA (nationwide) including Puerto Rico and internationally to Hong Kong.
- Date initiated
- 2013-10-29
- Date posted
- 2013-11-22
- Date terminated
- 2014-03-17
- Location
- Fremont, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MAS LIQUID URINALYSIS CONTROL LEVEL 1, LEVEL 2 AND LEVEL 3 (K973451) | Medical Analysis Systems, Inc. | 1997-09-29 |