Tosoh Smd Recalls
3 recalls on record · August 7, 2013 to January 1, 2020 · Medical Devices
Recalls by year
13
17
20
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
January 1, 2020Medical DevicesFDA
Tosoh Smd Inc recalls AIA-PACK B12 Pretreatment Set- IVD for diagnostic use for pre-treatment of calibrators/controls. Part Number: 020706
Hazard: The AIA-2000 bar code scanners depend on the quiet zone to help identify the bar code. The lack of an adequate quiet zone can cause the bar code scanner to confuse the bar codes with text or graphics resulting in the scanner ignoring a valid symbol. This results in an error in reading the barcode: Error Code 2220 Unable to read barcode on reagent bottle . In some cases, the quiet zone is too short and an error in barcode reading occurs. The problem is intermittent and not all vials (6 vials are available per set) have been reported to fail. The only risk to patients or users is a delay in results. The company recommends (optional) that customers pre-screen the vials to identify affected products. Customers can contact the company for reimbursement of any affected products. The company has implemented barcode checks as a temporary solution and will replace the barcode printer on the production line for products beginning with lot B*01898.
March 1, 2017Medical DevicesFDA
Tosoh Smd Inc recalls Keyspan High-High Speed USB to Serial Adapter Product Usage: The Reporting Software is an application which serves a
Hazard: Power outages causes reporting software to shutdown.
August 7, 2013Medical DevicesFDA
Tosoh Smd Inc recalls AIA Analyzer Pipette Tips used on Tosoh AIA-2000, AIA-1800, AIA-900 and AIA-600II Analyzers, 1000 tips/bag AIA-Analyz
Hazard: Visual inspection of the pipette tips indicated that some of the tips were not uniform in size/length which was causing error messages on the analyzers.