Medical device recalls

Product fails to meet the performance claims quoted on the kit insert: Manual Procedure when calibrating using the standard provided in the kit, the change in absorbance is lower than expected generating internal quality control results high outside range; Cholesterol (CHOL) Instrument Specific Application using the recommended calibration material CAL2351, the product fails to meet its linearity performance claim quoted on the kit inserts. The linearity is reduced by up to -35% however Quality Control results will still fall within assigned ranges. This may lead to delayed results.

A customer reported a problem with the reagent and calibrator. Randox Laboratories carried out an investigation and confirmed the issue. The complaint is pertaining to atypical calibration curves that can results in non-numerical results. This affects Siemens Atellica CH analysers only. Customer have reported an atypical calibration curve that results in the values around the low QC range to produce a non-numerical result. It appears to be related to the bottle values of the calibrator producing a curve shape that is too linear for the logitlog calculation to calculate. This issue can only be identified in the Atellica graphical view of the calibration. In most of the cases when this has occurred, it is picked up by the QC generating a Math Error, however, there are reports of QC shifts after calibration without the Math Error flagged that may be related to this issue. Results reported with STFR Level 1, with a concentration less than 1.7mg/L, using TF10159 and TF10161 can be underestimated by up to 30%. This issue has been reported with reagent lots 575475 and 562691, calibrator lots 537725 and 562696. No other complaints received.

A customer reported a problem with the reagent and calibrator. Randox Laboratories carried out an investigation and confirmed the issue. The complaint is pertaining to atypical calibration curves that can results in non-numerical results. This affects Siemens Atellica CH analysers only. Customer have reported an atypical calibration curve that results in the values around the low QC range to produce a non-numerical result. It appears to be related to the bottle values of the calibrator producing a curve shape that is too linear for the logitlog calculation to calculate. This issue can only be identified in the Atellica graphical view of the calibration. In most of the cases when this has occurred, it is picked up by the QC generating a Math Error, however, there are reports of QC shifts after calibration without the Math Error flagged that may be related to this issue. Results reported with STFR Level 1, with a concentration less than 1.7mg/L, using TF10159 and TF10161 can be underestimated by up to 30%. This issue has been reported with reagent lots 575475 and 562691, calibrator lots 537725 and 562696. No other complaints received.

There was translation error in the Spanish version of the IFU where the Spanish version instructs the user to leave the blastocyte to air thaw for 5 minutes rather than the correct 5 seconds as indicated in the English version.

Firm has received complaints on the device concerning leak/rupture of either the bronchial or tracheal cuff. Leakage during procedure could lead to loss of secure airway and will require re-intubation of patient.

Manufactured with a Galvanized High Carbon Steel spring instead of the correct 302 Stainless steel spring. has the potential to oxidize and corrode in the ATTUNE Measured Sizing & Rotation Guide, resulting in surgical delay, debris in surgical field, Osteolysis, Poor Joint Mechanics, Soft Tissue Irritation, Pain

The product was mispackaged (swapped). The devices within the inner tray matches the inner tray but does not match the outer box label and the chart sticks.

The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate Management feature used to pull heat and moisture away from the patient resulting in an increased patient risk of pressure ulcer development.

The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate Management feature used to pull heat and moisture away from the patient resulting in an increased patient risk of pressure ulcer development.

The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate Management feature used to pull heat and moisture away from the patient resulting in an increased patient risk of pressure ulcer development.

The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate Management feature used to pull heat and moisture away from the patient resulting in an increased patient risk of pressure ulcer development.

The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate Management feature used to pull heat and moisture away from the patient resulting in an increased patient risk of pressure ulcer development.

The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate Management feature used to pull heat and moisture away from the patient resulting in an increased patient risk of pressure ulcer development.

The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate Management feature used to pull heat and moisture away from the patient resulting in an increased patient risk of pressure ulcer development.

Set screwdriver fails during surgery by deforming at the tip during engagement and manipulation of the implant.

Malfunction of the robotic arm preventing further movement of the robotic arm and requiring restart of the robotic digital microscope system.

Some nonsterile components that were supposed to be sterile were packaged in nonsterile kits.

Some nonsterile components that were supposed to be sterile were packaged in nonsterile kits.

Customized coronal rod benders may deform the implant when used with the spinal system devices.

Customized coronal rod benders may deform the implant when used with the spinal system devices.

There is a potential compatibility issue with the systems and replacement treatment applicators.

An issue with propagation of treatment course information from RayStation with RayTreat to RayCare has been identified. During some workflows, information may not be propagated to RayCare.

Some Canister Scanning Labels used to calibrate the Triton Canister System have a color variance. Based on a comprehensive analysis, blood loss estimates obtained using these Canister Scanning Labels may result in lower than expected results.

There is the potential that YelloPort Elite Universal Seals packaging may contain small holes which may affect the sterility of the product.

Gauss Surgical is updating the Instructions for Use (IFU) for our Triton Sponge System in order to clarify proper technique for handling sponges and the calibration placard.

Firm has revised labeling to consistently call out storage conditions and revised the instructions for use to clarify that the temperature range symbol is intended to indicate storage conditions (versus transport conditions or tolerance conditions for the package material).

Several complaints were received for the affected lot; users received a "Fiber type does not match card type" error message on the GreenLight XPS Laser console, necessitating the replacement of the laser fiber and fiber card. This may result in prolonged procedure while the fiber is being replaced.

Nonfunctional key due to the potential for damage to the key pins cause by force of use during assembly of the tibia locking ring.

The Instructions for Use (IFU, Part Number 750095) provided with the affected lots by the firm contains an error associated with product s CE marking. The CE mark contained in the IFU is followed by the Notified Body designation, British Standards Institution number 2797 (BSI-2797) for product inserts 750095.28 and 750095.29. The erroneous label CE2797 were in the IFU insert revision 750095.28 for the 408 affected lots that were shipped. No product was packed with erroneous insert revision 750095.29. Since the product is currently CE marked as a Class I - self-certified product under the EU In Vitro Diagnostics Directive, the Notified Body designation should not be specified. As part of the corrective action, the firm has notified the customers who received the products with erroneous labeling, and is conducting the replacements with the correct product insert containing the Insert Revision 750095.30

There is a potential reversal of the O2 and air cylinder pressure transducer connections.