Recall Z-2884-2016— Microgenics Corporation
Class II · Terminated
Class II FDA medical device recall by Microgenics Corporation, initiated 2016-07-25, terminated 2016-11-21. It names one FDA 510(k) clearance: K961131. Product: 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.. 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..
- Recalling firm
- Microgenics Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-07-25
- Terminated
- 2016-11-21
- Firm location
- Fremont, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
Some lots of DRI Salicylate Serum Tox Assay negative patient samples are recovering higher than the product sensitivity claim of 4.4 mg/dL.
Data sourced from openFDA. This site is unofficial and independent of the FDA.