Recalls: Baxter Prismaflex

The FDA has announced recalls of all lots and serial numbers of the following Baxter Prismaflex products, for installation of new firmware:

The FDA does not include a link to recall instructions.

Recall: Roche Accu-Chek Aviva/Performa Test Strips

Certain lots of Accu-Chek Aviva and Performa test strips have been recalled by Roche Diabetes Care because some strips may give error messages or incorrect readings, which could result in treatment errors.  Lots recalled include:

  • Accu-Chek Aviva 10 test strip pots, lots #497344, 497392
  • Accu-Chek Aviva 50 test strip pots, lots #496802, 496807, 496809, 496915, 497391, 497392
  • Accu-Chek Performa 10 test strip pots, lots #476597, 476646
  • Accu-Chek Performa test strips in Nano blood glucose kits, lots #10153111, 10153112, 10153114, 10153115, 10153116

For more information see https://www.diabetes.co.uk/news/2018/may/roche-announces-urgent-recall-on-certain-accu-chek-aviva-and-performa-test-strips-91431166.html.

Recall: FMC 2008 K2 HD Machines

The FDA has announced a Class II recall of 127 Fresenius 2008 K2 Hemodialysis Machines with software version 5.40, Models: (1) Hemodialysis SYS OLC/Diasafe PLS 190610, UDI 00840861100859 (+Serial Number), and (2) Machine Short Cap, OLC.DP HP 190630, UDI 00840861100866 (+Serial Number) indicated for acute and chronic dialysis therapy because of software errors.  For serial numbers and other details see https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=162434.