Instrumentation Laboratory recalls HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (OUS only)
Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.
Read the official notice →- Date
- 2026-10-21
- Country
- United States
- Brand
- Instrumentation Laboratory
- Product
- HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (OUS only)
- Classification
- Class I
- Units
- Worldwide - US Nationwide distribution in the states of AR, AZ, CA, CT, FL,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Instrumentation Laboratory recalls
- 2026-08-12
Instrumentation Laboratory recalls GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010 00055430010 00055430011 00055445010 00055445011…
The active ingredient concentration in the lysing bag solution of specific GEM Premier 5000 lots did not meet established manufacturing specifications. The malfunction could result in delayed recognition and management…
FDA · DeviceInstrumentation LaboratoryWorldwide - US Nationwide distribution in the states of AZ, CA, FL, GA, IL,…Official notice →- 2026-08-05
Instrumentation Laboratory recalls Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Portable blood analyzer system
Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.
- 2026-03-18
Instrumentation Laboratory recalls GEM Premier 5000 PAK, Part No. 00055360004.
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including…
FDA · DeviceInstrumentation LaboratoryWorldwide distribution - US Nationwide and the countries of Argentina,…Official notice →- 2026-01-21
Instrumentation Laboratory recalls The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin…
Potential for microbial contamination.
FDA · DeviceInstrumentation LaboratoryWorldwide - US Nationwide distribution in the states of CA, FL, IL, MN, MS,…Official notice →- 2025-12-24
Instrumentation Laboratory recalls HemosIL SynthAFax. Partial Thromboplastin Time Tests.
Recalled lots were manufactured with double the amount of preservative concentration.
FDA · DeviceInstrumentation LaboratoryDomestic: CA, CO, FL, NY; Foreign: AR, AT, CA, CZ, DE, DK, ES, FR, GB, IE, IL,…Official notice →- 2025-08-20
Instrumentation Laboratory recalls HemosIL LMW Heparin Controls; Part Number: 0020300200;
Multiple complaints indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range when testing is performed with HemosIL…
FDA · DeviceInstrumentation LaboratoryWorldwide - US Nationwide and the countries of Algeria, Andorra, Argentina,…Official notice →
USOther drugs & medical recalls in the United States
- 2026-10-21
Becton Dickinson & Co. recalls BD Phoenix Panel NMIC-312. Catalog Number: 449082.
Potential for quality control failures with Klebsiella pneumoniae ATCC BAA-1705 when using the CPO Ambler classification feature.
Medtronic Sofamor Danek USA Inc recalls Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert additive to yield a…
Medtronic identified through donor record review that the donor for Medtronic batch A62881 did not meet all Medtronic donor eligibility requirements related to the presence of microbial organisms. While the batch…
FDA · DeviceMedtronic Sofamor Danek USA IncUS Nationwide distribution in the states of OK, VA, CO, AR, FL, TX, MD, DE,…Official notice →Jenavalve Technology Inc. recalls JenaValve Trilogy Delivery Catheter, Size 27MM REF: TRILOGY-DC-L
Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.
FDA · DeviceJenavalve Technology Inc.US Nationwide distribution in the states of AZ, CA, FL, GA, IL, MA, MD, MI,…Official notice →