The Lactobacillus acidophilus negative control (item 0243 single KWIK-STIK) contained in the 8164 Cepheid Xpert GBS QC Set and 8165 Cepheid Smart GBS QC Set was found to test positive for Group B Streptococcus (GBS) in some cases. This causes a failure when used as a quality control for the Cepheid Xpert GBS and Cepheid Smart GBS systems. The failure of the quality control test causes a disruption for the testing laboratory which may result in repeated testing or the need for alternative test methods. This recall is applicable to the 8164 and 8165 sets only.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
Class I - Dangerous
There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.
Product was labelled with the incorrect manufacturing and distribution dates.
Class I - Dangerous
There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.
da Vinci Xi and X 12-8 mm Conductive Cannula Reducer, REF: 470381-11
Intuitive Surgical
Class I - Dangerous
Conductive Cannula Reducer metal tip may get dislodged from the plastic shaft. If unnoticed, additional surgery may be required to remove the metal tip. If the procedure proceeds without the metal tip, there is potential for energy leakage, which could cause tissue damage. If the metal tip remains in the patient, adhesions may form, which may lead to bowel obstruction and chronic abdominal pain.
Philips Respironics V60 Ventilator Part Number 1053617
Respironics California
Class I - Dangerous
A limited number of ventilators were assembled with expired adhesive. If the adhesive fails, a bracket may become loose and potentially damage the capacitors, which could cause the ventilator to stop providing ventilation to the patient. This failure may either activate both visual and audible alarms, or it may not sound or display an alarm (a silent shutdown).
MEDLINE Micro-Kill Bleach Germicidal Bleach Wipes
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
Micro-Kill Bleach Wipes contain out of specification (low) levels of Sodium Hypochlorite.
Alinity m Integrated Reaction Units (IRU)
Abbott Molecular
Class I - Dangerous
There is potential for the Reaction Vessels (RVs) detaching from the RV cap during transport by the pipettor robot.
Digital Angiography System Bransist safire Generator Model D150GC-40
Shimadzu Medical Systems
Class I - Dangerous
Due to the inadequate adjusting criteria in installation, the system generator on two Digital Angiography Systems, the irradiated x-ray may exceed the x-ray radiation dose rate in fluoroscopic mode.
Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Neisseria gonorrhoeae Strain GL0071.
Microbiologics
Class I - Dangerous
Real-time shelf life testing failed at 24 months
Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE Dry eye treatment
Lacrimedics
Class I - Dangerous
The sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility.
BUTLER Clear Dip, 12 bottles/case
Sunstar Americas
Class I - Dangerous
Product lacks premarket clearance.
The labeling for the Microbiology Brush identifies the device as a Bronchial Microbiology Brush. The device is only cleared for gastrointestinal use and is not cleared for bronchial use.
Class I - Dangerous
There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.
Real-time shelf life testing failed at 24 months
Class I - Dangerous
Products are mislabeled with the incorrect product identification on individual kit labeling.
Class I - Dangerous
This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Synergy. A specific lot was found susceptible to Gentamicin Synergy during in-house testing.
Class I - Dangerous
The affected lot was placed under quarantine in September 2021 due to complaints of alleged false positives, but 243 kits were erroneously released to customers in December 2021.
The Lactobacillus acidophilus negative control (item 0243 single KWIK-STIK) contained in the 8164 Cepheid Xpert GBS QC Set and 8165 Cepheid Smart GBS QC Set was found to test positive for Group B Streptococcus (GBS) in some cases. This causes a failure when used as a quality control for the Cepheid Xpert GBS and Cepheid Smart GBS systems. The failure of the quality control test causes a disruption for the testing laboratory which may result in repeated testing or the need for alternative test methods. This recall is applicable to the 8164 and 8165 sets only.
Class I - Dangerous
Returned test kits were erroneously shipped to customers. The kits are intended for Research Use Only (RUO). Additional RUO test kits were shipped to customers unlikely to use them for RUO purposes, and the firm provided a letter assuring distributors that RUO tests could be used for clinical diagnosis.