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Other Medical Devices

🏥 Medical Devices 15,203 recalls

Class I - Dangerous

Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.

Jun 23, 2022 Other Medical Devices Nationwide View Details →

Incorrect expiration date listed on the product labels. The expiration date listed on the product label is beyond the expiration date of the product.

Jul 18, 2022 Other Medical Devices Nationwide View Details →
Class I - Dangerous

SARS-CoV-2 assay that detects SARS-CoV-2 ORF1ab and N genes may not detect the ORF1ab gene. A positive results if either SARS-CoV-2 genes is detected, but If both genes are mistakenly not detected, a false negative result would be generated.

Jul 14, 2022 Other Medical Devices Nationwide View Details →
Class I - Dangerous

Mis-wired component-the improperly wired component can result in additional noise on the power supply output. Noise on the ultrasonic input circuit is not consistent with electromagnetic compatibility (EMC) standards and may decrease the overall reliability of the system and result in delay of treatment

Jul 7, 2022 Other Medical Devices Nationwide View Details →

As a result of unclear guidance in the service manual, the table can drop during a specific service activity if the wrong screws are removed by the service personnel without the appropriate table supports in place resulting in injury to service personnel.

Jun 2, 2022 Other Medical Devices Nationwide View Details →

cobas e801 Immunoassay Analyzer

Roche Diagnostics Operations

Class I - Dangerous

Software issue resulting in signals and sample test results of Pre-Wash tests being impacted. The following assays are considered impacted by the issue: Anti-HAV2, Anti-HBc IgM, IGF-1, Myogloin, Rubella IgG, and Toxo IgG.

Jul 14, 2022 Other Medical Devices Nationwide View Details →