Complete FDA and NHTSA recall records dated in December 2018.
These records include useful source details for the selected month.
Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene…
Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene…
Table may drift in the roll position while in use
Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.
Unintentional U-Arm movement
Cosmetic imperfections on the surface of some lenses.
Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene…
There have been reports of shortened (T1-T2) results, where some instances of result recovery outside of the range of less than or equal to 15 seconds.
Table may drift in the roll position while in use
In some situations the carousel position pin (locker) may cause the carousel upper plate to pop out and the carousel may then inadvertently move.
Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.
Inaccurate potassium results may be generated. When testing with control fluid and/or patient samples with low or reference range potassium concentration, elevated potassium results may be…
Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene…
Mislabeled Labeled Avenir M¿ller Stem size 1, the stem inside the packaging is an Avenir M¿ller Stem size 2 .
RBC Reagent failure. High fluorescent counts during RBC Reagent + Diluent QC check that will result in failed QC check, preventing user from testing patient samples for RBC.
The firm has become aware of a potential issue with the AIA-360 analyzer that could prevent the table home sensor from detecting the table home position. If the malfunction with the table…
Screw is missing from the package
Siemens Healthcare Diagnostics has identified an issue with Dimension Vista software v.3.7 and v.3.8.1 that may result in aliquot well contamination. If a test is cancelled by the operator…
Software Update: External USB Drive performance and its impact on Graphic User Interface (GUI) functionality and labeling of the scalar waveform displayed on GUI during ventilation
Table may drift in the roll position while in use
False resistant results for Streptococcus anginosus and Streptococcus constellatus strains were reported.
Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene…
The product was released into commercial distribution while subject to importation refusal.
The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the…
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.
