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Problem: In a February 11, 2011, Urgent Product Correction letter submitted by an ECRI Institute member hospital, Beckman Coulter states that the above analyzers may experience the following problems: (1) Specimen tubes may fall out of a type A cassette (product number A53551) when the analyzer inverts the cassette in the mixing station or when an operator manually inverts a cassette. This may cause the tubes to be misplaced inside the analyzer or break upon impact, resulting in the need to redraw patient samples to replace lost or broken tubes. (2) The analyzers may fail to meet the carryover specification for the white blood cell (WBC) differential (DIFF) when the WBC is >70 × 103 cells/µL (70 × 109 cells/L). (3) The analyzers may fail to meet the carryover specification for nucleated red blood cell (NRBC) percentage when the WBC is >50 × 103 cells/µL (50 × 109 cells/L). (4) The handheld barcode scanner may not read barcode labels using NW7 symbology, preventing the reading of any specimen tubes with NW7 labels. The manufacturer has not confirmed the information provided in the source material. Manufacturer: Designation: Beckman Coulter Reference No. PCA 16478 Action Needed: Verify that you have received the February 11, 2011, Urgent Product Correction letter and response form from Beckman Coulter. Identify any affected product in your inventory. Beckman Coulter recommends that you perform the following actions to prevent the above problems: (Problem 1) Periodically inspect the mix station's drip tray for misplaced tubes that may have fallen from the cassette and examine the type A cassettes to determine if the expandable grippers (clips) within the lavender-colored insert are stuck in the open position (tubes will be loose). Contact your Beckman Coulter local representative if you need assistance with any questionable grippers. Clean any spills according to your laboratory's standard operating procedures. (Problem 2) No action or review of previously obtained results is required. (Problem 3) No action or review of previously obtained results is required. (Problem 4) NW7 barcode labels can be read using 1 of the following methods: Using the internal barcode scanner at the single-tube presentation station By entering the barcode information manually at the user interface of the single-tube station By using the cassette presentation Inform all relevant laboratory personnel of the information in the Urgent Product Correction letter and forward a copy of the letter to any facility to which you have further distributed affected product. Beckman Coulter will correct these problems in future releases of UniCel DxH 800 analyzers. Complete the response form, and return it to Beckman Coulter using the information on the form. For Further Information: Geographic Location: Contact: Telephone No.: Website: U.S. and Canada Beckman Coulter customer service department (800) 526-7694 Click here Outside the U.S. and Canada Beckman Coulter local representative

Mon Feb 28 2011By Amy Hartman

Problem: In a February 11, 2011, Urgent Product Correction letter submitted by an ECRI Institute member hospital, Beckman Coulter states that the above analyzers may experience the following problems: (1) Specimen tubes may fall out of a type A cassette (product number A53551) when the analyzer inverts the cassette in the mixing station or when an operator manually inverts a cassette. This may cause the tubes to be misplaced inside the analyzer or break upon impact, resulting in the need to redraw patient samples to replace lost or broken tubes. (2) The analyzers may fail to meet the carryover specification for the white blood cell (WBC) differential (DIFF) when the WBC is >70 × 103 cells/µL (70 × 109 cells/L). (3) The analyzers may fail to meet the carryover specification for nucleated red blood cell (NRBC) percentage when the WBC is >50 × 103 cells/µL (50 × 109 cells/L). (4) The handheld barcode scanner may not read barcode labels using NW7 symbology, preventing the reading of any specimen tubes with NW7 labels. The manufacturer has not confirmed the information provided in the source material. Manufacturer: Designation: Beckman Coulter Reference No. PCA 16478 Action Needed: Verify that you have received the February 11, 2011, Urgent Product Correction letter and response form from Beckman Coulter. Identify any affected product in your inventory. Beckman Coulter recommends that you perform the following actions to prevent the above problems: (Problem 1) Periodically inspect the mix station's drip tray for misplaced tubes that may have fallen from the cassette and examine the type A cassettes to determine if the expandable grippers (clips) within the lavender-colored insert are stuck in the open position (tubes will be loose). Contact your Beckman Coulter local representative if you need assistance with any questionable grippers. Clean any spills according to your laboratory's standard operating procedures. (Problem 2) No action or review of previously obtained results is required. (Problem 3) No action or review of previously obtained results is required. (Problem 4) NW7 barcode labels can be read using 1 of the following methods: Using the internal barcode scanner at the single-tube presentation station By entering the barcode information manually at the user interface of the single-tube station By using the cassette presentation Inform all relevant laboratory personnel of the information in the Urgent Product Correction letter and forward a copy of the letter to any facility to which you have further distributed affected product. Beckman Coulter will correct these problems in future releases of UniCel DxH 800 analyzers. Complete the response form, and return it to Beckman Coulter using the information on the form. For Further Information: Geographic Location: Contact: Telephone No.: Website: U.S. and Canada Beckman Coulter customer service department (800) 526-7694 Click here Outside the U.S. and Canada Beckman Coulter local representative
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