FDA Device Recalls

Class IIITerminated

Software Package, Sorting-Drive 4.2.1 User Kit for Windows XP and Windows 10, Part No. B95347, Manufactured by: Beckman Coulter Biomedical GmbH The Sorting-Drive itself is an optional software to be used with the Automate 2500 Family of products. . The Sorting-Drive 4.2.1 User Kit includes the Sorting-Drive Client software application that includes an option for manual printing of barcodes for sample tubes; version 4.2 was replaced by version 4.2.1 (they both contain the same option for manual barcode printing). This function is primarily used to copy an existing barcode ID to replace the label of an individual sample tube because the original label is deteriorated.

Beckman Coulter Inc.

Sorting-Drive software version 4.2 (released in October 2015) introduced a new option which included the Sorting-Drive Client that is used for manual printing of barcodes; version 4.2 was replaced by 4.2.1 (they both contain the same option for manual barcode printing). When printing consecutively numbered tube labels using this optional Barcode Counter function, the system incorrectly converts numbers with consecutive multiple zeroes in the middle, potentially leading to wrong barcode IDs.The firm reports this does not affect automated label creation or reprinting of individual labels and that no other system functions are affected.

May 24, 2018 · DeviceView details →

Collagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platelet aggregation studies, Contains: Collagen (equine tendon) For In-Vitro Diagnostic Use,

Vivo 65, Continuous Ventilator, Home Use, Cat. No. 204000 Product Usage: To provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation

Syva¿ EMIT¿ II Plus 6-Acetyl morphine Catalog # for 28 mL: 9R039UL /SMN# 10470440

Syva¿ EMIT¿ II Plus 6-Acetylmorphine Catalog # for 1000 mL: 9R129UL /SMN# 10481483

BD MAX DNA MMK (SPC) For Laboratory Use, catalog no. 442829

BD MAX DNA MMK Lab Use, catalog no. 442828

SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation and quantitation of hemoglobins by agarose electrophoresis using the SPIFE systems

Strauss Penis Clamp 130MM/General Instruments

Doyen-Collin Mouth Gag 120MM/ General Instruments