Recall Z-0383-2014 ยท JJW Urinalysis Controls (Assayed And Unassayed)
Thermofisher Scientive
MAS Urinalysis Control Level 1, Multi-analyte control (Assayed and Unassayed), Catalog/Part Numbers: 024222; Product is manufactured and distributed by Microgenics Corporation, a subsidiary of Thermo Fisher Scientific, Clinical Diagnostic Division, Fremont, CA MAS Urinalysis is intended for use in the clinical laboratory as a control for qualitative and semi-quantitative procedures used in routin
| Date | Nov 22, 2013 (initiated Oct 29, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 914 units |
| Distribution | Worldwide Distribution - USA (nationwide) including Puerto Rico and internationally to Hong Kong. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K973451 | MAS LIQUID URINALYSIS CONTROL LEVEL 1, LEVEL 2 AND LEVEL 3 Medical Analysis Systems, Inc., Sep 29, 1997 |