Class I - Dangerous
Incorrect expiration date included in test kit labeling and/or in Substrate component label.
🏨
Other Medical Devices
🏥 Medical Devices • 15,203 recalls
Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602, Catalog Number 06368590190
Roche Diagnostics Operations
Class I - Dangerous
Recent internal verification studies found the current RF interference claim to no longer be met for the assay on the cobas e 411, 601, and 602 analyzers. Therefore, the claim has been updated.
Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x1/16 UAS BLK, Catalog Number 5785 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the line during extracorporeal procedures.
Terumo Cardiovascular Systems
Class I - Dangerous
Internal testing at the supplier, revealed that a crimped wire was placed into an air bubble detector (ABD) sensor connector backwards, preventing the crimped wire from locking into the mating wire connector. This intermittent connection may result in false air bubble alarms.
Class I - Dangerous
US-dates between the product package label and the bar code display.
Class I - Dangerous
Multiple or incorrect expiration dates were provided on the affected designation labels.
Alaris System PC Unit Model 8015
CareFusion 303
Class I - Dangerous
The pump module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress potentially resulting in a delay to the start of infusion, interruption of infusion, or inability to titrate medication. For high-risk patient populations who are receiving life-sustaining infusions, delays in an infusion or interruption can cause serious injury or death.
The linear shrinkage on the zirconia blank disc s part label is incorrect. The average linear shrinkage found on the product label was outside the acceptable range. The acceptable average linear shrinkage ranges between 1.225 to 1.275. The production lot being recalled has a linear shrinkage rate of 2.251 which is above the acceptable range.
Class I - Dangerous
The pump module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress potentially resulting in a delay to the start of infusion, interruption of infusion, or inability to titrate medication. For high-risk patient populations who are receiving life-sustaining infusions, delays in an infusion or interruption can cause serious injury or death.
Merge PACS
Merge Healthcare
Class I - Dangerous
Measurements done on the Merge PACS generated MPR s may have incorrect measurements.
The product contains a non-functional component not referenced in product labeling.
Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent
RANDOX LABORATORIES
Class I - Dangerous
Amylase AY3805 batch 480449 and Pancreatic Amylase AY3855 batch 480483 have failed to meet the quoted performance claims prior to expiry on 28th Sept 2020.
Class I - Dangerous
Printed label inside the box lid of the Parvovirus has the incorrect Lot Specific Constant value
Class I - Dangerous
The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm, were found to have a labeling error. Exactech is recalling the Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm because they were found to have a labeling error. The upper right corner of the label incorrectly identifies the implant size as 3 when the implant size is 4.
The product contains a non-functional component not referenced in product labeling.
The product contains a non-functional component not referenced in product labeling.
Class I - Dangerous
Holding force of the Positioning Arm can be reduced by prolonged non-use.
The product contains a non-functional component not referenced in product labeling.
The product contains a non-functional component not referenced in product labeling.
The product contains a non-functional component not referenced in product labeling.
Pancreatic Amylase AY3855 batch 480483 Pancreatic Amylase Ethylidene Blocked-pNPG7 Reagent
RANDOX LABORATORIES
Class I - Dangerous
Amylase AY3805 batch 480449 and Pancreatic Amylase AY3855 batch 480483 have failed to meet the quoted performance claims prior to expiry on 28th Sept 2020.