HemosIL PT-Fibrinogen HS PLUS — Class II medical device recall Z-0832-2015
Terminated recall by Instrumentation Laboratory Co., reported 2014-12-31, distributed nationwide. Some vials of HemosIL PT-Fibrinogen HS PLUS, Part No. 0008469810 (various lots manufactured prior to June 2014
| Recall number | Z-0832-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Instrumentation Laboratory Co., Bedford, MA, United States |
| Recall initiated | 2014-11-21 |
| Classified | 2014-12-19 |
| Reported by FDA | 2014-12-31 |
| Terminated | 2016-01-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BG, BR, CH, CL, CN, CR, CZ, DE, DK, DO, DZ, EC, ES, FR, GB, GR, GT, HK, HR, ID, IE, IL, IN, IR, IT, JP, KE, KW, LB, LK, LT, LV, MT, MX, MY, NZ, PA, PH, PK, PL, PT, PY, RO, RS, RU, SG, TR, UA, UY, ZA |
| Lot numbers | 2015, 7/31, E0333382, N0132936, N0148094, N0233302, N0248652, N0249017, N0333382, N0333626, N0349325, N0433932, N0440009, N0449790, N0634953, N0735317, N0735599, N0836106, N0936197, N1122175, N1222324 |
| Expiration dates | 2014-11-30, 2015-01-31, 2015-02-28, 2015-03-31, 2015-04-30, 2015-05-31, 2015-06-30, 2015-08-31, 2015-09-30, 2015-12-31, 2016-02-29, 2016-04-30 |
Product
HemosIL PT-Fibrinogen HS PLUS, IVD --- Instrumentation Laboratory IL Company. A high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative determination in human citrated plasma of Prothrombin Time (PT) and Fibrinogen on IL Coagulation Systems. The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy (OAT).
Reason for recall
Some vials of HemosIL PT-Fibrinogen HS PLUS, Part No. 0008469810 (various lots manufactured prior to June 2014) exhibit a yellow/brownish color after reconstitution (yellow color or darker) instead of the typical white to off-white color. Vials exhibiting this yellow/brownish color were observed to cause prolonged prothrombin (PT) 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-0832-2015. 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.