Food, drugs, devices › Instrumentation Laboratory Co.
Device recall: Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage - HemosIL¿ ReadiPlasTin is an in vitro diagnos
FDA enforcement event 80932 is a device recall by Instrumentation Laboratory Co. of Bedford, MA, initiated 1 Aug 2018 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 16 Apr 2019. Initiation: voluntary: firm initiated. Instrumentation Laboratory Co. has 10 enforcement events on this register, with a median of 3 product records 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 Co., Bedford, MA.
Reason for recall
"There is a potential for increased imprecision, out of range quality controls and prolonged sample results."
Distribution
"US Nationwide"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0077-2019 | Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage - HemosIL¿ ReadiPlasTin is an in vitro diagnostic thromboplastin reagent, based on recombinant human tissue factor, for the quantitative determination, in human citrated plasma, of Prothrombin Time (PT) and Fibrinogen, on the ACL TOP¿ Family of… | 9751 kits | Class II | Terminated | 17 Oct 2018 |
Context
Other enforcement events for Instrumentation Laboratory Co.
All 10 events for Instrumentation Laboratory Co.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "There is a potential for increased imprecision, out of range quality controls and prolonged sample results."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 16 Apr 2019. "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.