Recall Register

Instrumentation Laboratory: FDA recalls

FDA enforcement reports name Instrumentation Laboratory as the recalling firm in 14 events. The events have 46 product records. The recalls started from 2021 to 2026. All the events are device recalls.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

14 events, newest first.

FDA enforcement events of Instrumentation Laboratory
InitiatedProduct (first record)TypeClassRecordsStatus
21 May 2026GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510 00077415004 00077415008 00077415010 00077430010 Product Description: The GEM Premier 7000 with iQM3 is a portable critical care system for use by health care professionals to rapidly analyze lithium heparinized whole blood samples at the point of health…DeviceClass II2Ongoing
8 May 2026GEM Premier 5000 with IQM2 Model/Catalog Number: 00024019255 and GEM Premier 7000 with iQM3 Model/Catalog Number: 00000015279 Portable blood analyzer system. Affected Accessory: Bar Code Reader (BCR) Wand Part No. 00024015859DeviceClass II6Ongoing
20 Jan 2026GEM Premier 5000 PAK, Part No. 00055360004.DeviceClass II20Ongoing
11 Dec 2025The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.DeviceClass II1Ongoing
18 Nov 2025HemosIL SynthAFax. Partial Thromboplastin Time Tests.DeviceClass III1Ongoing
3 Feb 2025HemosIL LMW Heparin Controls; Part Number: 0020300200;DeviceClass II1Ongoing
18 Dec 2024HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnosticDeviceClass II1Ongoing
29 Sep 2023GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330004, 00024345004DeviceClass II3Ongoing
13 Jul 2023ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis (1) ACL TOP 550 CTS Model Number: 00000280045; (2) ACL TOP 750 CTS Model Number: 00000280055; (3) ACL TOP 350 CTS…DeviceClass II1Ongoing
3 Feb 2023ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311DeviceClass II4Ongoing
8 Apr 2022HemosIL ReadiPlasTin, Part No. 0020301400DeviceClass II1Ongoing
22 Feb 2022ACL TOP 300 CTS/350 CTS/500 CTS/550 CTS/970 CL: Name Part Number 1.ACL TOP 300 CTS 00000280060 2. ACL TOP 300 CTS 00000280060R (Refurbished) 3. ACL TOP 350 CTS 00000280065 4. ACL TOP 500 CTS 00000280040 5. ACL TOP 500 CTS 00000280040R ( Refurbished) 6/ 6. ACL TOP 550 CTS 00000280045 7. ACL TOP 970 CL 00000280097DeviceClass II1Ongoing
13 Oct 2021HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent.DeviceClass II1Ongoing
25 Aug 2021HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL Coagulation Systems, (ACL TOP Family, ACL TOP Family 50 Seriest and ACL Elite/Elite Pro/8/9/10000) Part Number:…DeviceClass II3Ongoing

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

Instrumentation Laboratory: events for each product type
TypeEvents
Device14
Instrumentation Laboratory: events in each class
ClassEvents
Class II13
Class III1
Share of the events of the firm in Class I
0%
Share of all events on the register in Class I
18%
Events with the status Ongoing
14

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Instrumentation Laboratory, by the year that the recall started. The largest year is 2023, with 3 events.

Official channels

Cite this page

Recall Register. Instrumentation Laboratory: FDA recalls. https://recallregister.com/firm/instrumentation-laboratory/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
MA

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Instrumentation Laboratory have?
Class II: 13 events. Class III: 1 event. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Instrumentation Laboratory?
FDA event 99128, which the firm started on 21 May 2026. The first product in the record is: GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510 00077415004 00077415008 00077415010 00077430010 Product Description: The GEM Premier 7000 with iQM3 is a portable critical care system for use by health care professionals to rapidly analyze lithium heparinized whole blood samples at the point of health…
How many FDA recalls of Instrumentation Laboratory have the status Ongoing?
14 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.