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…
Read the official notice →- Date
- 2025-08-20
- Country
- United States
- Brand
- Instrumentation Laboratory
- Product
- HemosIL LMW Heparin Controls; Part Number: 0020300200;
- Classification
- Class II
- Units
- Worldwide - US Nationwide and the countries of Algeria, Andorra, Argentina,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2026-03-18
US
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
US
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
US
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 →- 2025-02-05
US
Instrumentation Laboratory recalls HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic
Control indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range.
FDA · DeviceInstrumentation LaboratoryWorldwide - US Nationwide and the countries of Andorra, Algeria, Armenia,…Official notice →- 2023-11-29
US
Instrumentation Laboratory recalls GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024315007, 00024330007, 00024345007, 00024360007
Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (i.e., positive bias) of pO2 results in the low range (at pO2 levels less than 60 mmHg) that are outside of labeled…
- 2023-09-20
US
Instrumentation Laboratory recalls ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or…
Sample misidentification could occur under specific conditions and patient management altered based on an incorrectly assigned result
FDA · DeviceInstrumentation LaboratoryWorldwide distribution - US Nationwide and the countries of Canada, Finland,…Official notice →
Other drugs & medical recalls in the United States
- 2025-08-27
US
US
- 2025-08-20
US
Diversatek Healthcare recalls Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10
Anorectal manometry procedure kit outer kit label is mislabeled with an incorrect expiration date; the manufacturing date was used in place of the expiration date. All inner labels on kit components display the correct…
FDA · DeviceDiversatek HealthcareWorldwide - US Nationwide distribution in the states of NM, MA, CO, OH and the…Official notice →US
Beckman Coulter, Inc. recalls Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860
Access Thyroglobulin reagent lot 439163 may generate erroneously high patient results. Falsely increased Access Thyroglobulin results may lead a physician to pursue unnecessary diagnostic imaging studies and/or…
FDA · DeviceBeckman Coulter, Inc.Worldwide - US Nationwide and the countries of Brazil, Canada, Georgia, Italy,…Official notice →US
CareFusion 303, Inc. recalls Description/REF: BD PYXIS MEDBANK MINI 1FH-1FM/169-137, BD PYXIS MEDBANK MINI 4HM/169-113, BD PYXIS MEDBANK MINI 4HH/169-112, BD PYXIS…
Reports of delayed access to medication in automated dispensing cabinets because of the override/Add Item workflow.
FDA · DeviceCareFusion 303, Inc.US Nationwide distribution including in the states of NY, MA, KY, VA, OR, OH,…Official notice →US
GE Medical Systems, LLC recalls GE Signa Artist, Nuclear Magnetic Resonance Imaging System
GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T,…