DRI Salicylate Serum Tox Assay — Class II medical device recall Z-2884-2016
Terminated recall by Microgenics Corporation, reported 2016-10-05, distributed nationwide. Some lots of DRI Salicylate Serum Tox Assay negative patient samples are recovering higher than the product se
| Recall number | Z-2884-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Microgenics Corporation, Fremont, CA, United States |
| Recall initiated | 2016-07-25 |
| Classified | 2016-09-23 |
| Reported by FDA | 2016-10-05 |
| Terminated | 2016-11-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, DE, HK, IT, MY, TW |
| Quantity | 1,708 kits |
| Reason classes | potency |
| Lot numbers | 60704602, 72035410, 72208738, 72409454 |
| Model numbers | 0977 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2884-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.