ROTEM ex-tem — Class II medical device recall Z-2485-2019
Terminated recall by Instrumentation Laboratory Co., reported 2019-09-18, distributed in IL, MI, WI. Prolonged clotting times
| Recall number | Z-2485-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Instrumentation Laboratory Co., Bedford, MA, United States |
| Recall initiated | 2019-07-23 |
| Classified | 2019-09-06 |
| Reported by FDA | 2019-09-18 |
| Terminated | 2020-04-27 |
| Distributed | IL, MI, WI |
| Countries outside the US | AR, AT, AU, BE, CA, CH, CY, CZ, DE, DK, ES, FR, GB, HK, HU, IE, IL, IN, IT, JO, JP, KR, LK, NL, PL, PT, RS, SE, SG, VN |
| Quantity | 364 kits |
| Lot numbers | 42255901 |
| Model numbers | 503-05-US |
Product
ROTEM ex-tem; US Part No: 503-05-US
Reason for recall
Prolonged clotting times
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-2485-2019. 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.