HemosIL Plasminogen — Class II medical device recall Z-0736-2016
Terminated recall by Instrumentation Laboratory Co., reported 2016-02-10. This Lot is not meeting labeled on-board instrument stability claims of 5 days.
| Recall number | Z-0736-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Instrumentation Laboratory Co., Bedford, MA, United States |
| Recall initiated | 2015-12-18 |
| Classified | 2016-02-01 |
| Reported by FDA | 2016-02-10 |
| Terminated | 2017-08-30 |
| Countries outside the US | AR, AT, BE, BR, CA, CN, CZ, DE, FR, GB, HK, IT, LT, PA, PL, RU, SA, VE |
| Reason classes | labeling, specification failure |
| Lot numbers | N0455811 |
| Model numbers | 0020009000 |
| Expiration dates | 2017-03-31 |
Product
HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Company. Kit contents: 2 x 2.5 mL Streptokinase reagent and 2 x 2 mL Chromogenic substrate
Reason for recall
This Lot is not meeting labeled on-board instrument stability claims of 5 days.
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-0736-2016. 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.