Siemens Healthcare Diagnostics ADVIA 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control) recall — FDA Z-2087-2025
Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
Complete FDA and NHTSA recall records dated in July 2025.
These records include useful source details for the selected month.
Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
Due to customer complaints, errors in spectral overlap factors table for 7-color setup beads may affect accurate setup of the flow cytometry instrument prior to analyzing samples.
Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae.
Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN which was identified that during insertion of the…
This device does not indicate for use in patients with respiratory failure.
Due to complaints, software update may cause software to unexpectedly shutdown.
Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect pre-use leakage test and use of an incorrect active…
Ultrasound transducer devices were refurbished beyond their useful life.
Cather packaging may contain the incorrect French size.
Ultrasound transducer devices were refurbished beyond their useful life.
Ultrasound transducer devices were refurbished beyond their useful life.
Ultrasound transducer devices were refurbished beyond their useful life.
Ultrasound transducer devices were refurbished beyond their useful life.
This device does not indicate for use in patients with respiratory failure.
Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN which was identified that during insertion of the…
U.S. customers were shipped devices that were configured for the European Union and were unable to plug the device in the electrical outlet.
Ultrasound transducer devices were refurbished beyond their useful life.
Ultrasound transducer devices were refurbished beyond their useful life.
Ultrasound transducer devices were refurbished beyond their useful life.
Ultrasound transducer devices were refurbished beyond their useful life.
Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
a software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the Use Expired Reagents setting is not…
Lots from Generation (GEN) 15 of VITROS Chemistry Products OP Reagent may generate lower than expected quality control (QC) results. If the customer is unable to get passing quality control…
Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.