Recall Z-2884-2016 ยท DKJ Colorimetry, Salicylate
Microgenics Corporation
DRI Salicylate Serum Tox Assay, Catalog number 0977. Toxicology: The DRI Salicylate Serum Tox Assay is intended for the quantitative determination of salicylate in human serum or plasma.
| Date | Sep 23, 2016 (initiated Jul 25, 2016) |
| Status | Terminated |
| Reason | Some lots of DRI Salicylate Serum Tox Assay negative patient samples are recovering higher than the product sensitivity claim of 4.4 mg/dL. |
| Root cause | Under Investigation by firm |
| Action | The firm, Thermo Fisher Scientific, sent an "URGENT MEDICAL DEVICE FIELD ACTION" letter dated July 25, 2016 by regular mail to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to determine if they are using or have inventory of any of the affected lots; discontinue use and destroy any remaining inventory of affected lots per local wastes ordinances; retain a copy of the letter for laboratory records; if you have forwarded kits of the affected lots, provide a copy of letter to them; and complete and return attached Medical Device Fi |
| Quantity | 1708 kits |
| Distribution | Worldwide Distribution: US (nationwide) to states of: AZ, CA, MO, TX, and PR and countries of: Canada, Germany, Hong Kong, Italy, Malaysia, and Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K961131 | SALICYLATE ASSAY Diagnostic Reagents, Inc., Apr 29, 1996 |