Food, drugs, devices › Instrumentation Laboratory
Device recall: HemosIL SynthAFax. Partial Thromboplastin Time Tests.
Instrumentation Laboratory (Bedford, MA) initiated this device recall on 18 Nov 2025; FDA lists 1 product record under event 98019, classified Class III.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 2% of the 945 device enforcement events initiated in 2025 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Instrumentation Laboratory has 14 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Instrumentation Laboratory, Bedford, MA.
Reason for recall
"Recalled lots were manufactured with double the amount of preservative concentration."
Distribution
"Domestic: CA, CO, FL, NY; Foreign: AR, AT, CA, CZ, DE, DK, ES, FR, GB, IE, IL, IN, IT, JP, LK, NL, PL, PT, RO, RS, TH, VN."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0938-2026 | HemosIL SynthAFax. Partial Thromboplastin Time Tests. | 4,506 units | Class III | Ongoing | 24 Dec 2025 |
Context
Other enforcement events for Instrumentation Laboratory
All 14 events for Instrumentation Laboratory
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Recalled lots were manufactured with double the amount of preservative concentration."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Domestic: CA, CO, FL, NY; Foreign: AR, AT, CA, CZ, DE, DK, ES, FR, GB, IE, IL, IN, IT, JP, LK, NL, PL, PT, RO, RS, TH, VN."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.