COULTER LH SlideMaker, LH Barcode Specification, LH SM Intended Use, LH Slide and Sample Flow, Part Number 6605633, P/N 4277248, 4277299, and 277299. Intended for use as an optional peripheral to the Beckman Coulter LH 700 Series System. Creates a blood smear on a clean microscope slide using a segment of the blood sample aspirated by the LH 700 Series.
Recall
- Recall Number
- Z-0850-2010
- Event Number
- 48978
- Firm
- Beckman Coulter Inc
- FEI Number
- 2050012
- Product Code
- KPA
- Status
- Terminated
- Root Cause
- Pending
- Initiated
- May 29, 2008
- Posted
- February 25, 2010
- Terminated
- November 29, 2011
- Address
- 200 S Kraemer Blvd, Brea, CA, 92822-6208
Description
COULTER LH SlideMaker, LH Barcode Specification, LH SM Intended Use, LH Slide and Sample Flow, Part Number 6605633, P/N 4277248, 4277299, and 277299. Intended for use as an optional peripheral to the Beckman Coulter LH 700 Series System. Creates a blood smear on a clean microscope slide using a segment of the blood sample aspirated by the LH 700 Series.
Beckman Coulter has become aware of a potential issue in which the Sample ID information embedded in the barcode affixed to a slide made by the Coulter GEN*S and LH SlideMaker does not match the text.
An Urgent: Product Corrective Action letter, dated June 9, 2008, was sent to customers. The letter identified the affected products, stated the background, discussed the issue, and stated the actions to be taken. Customers are to: 1. Only use upper case alpha characters in the Sample Identifier 2. If you must use lower case alpha characters in the Sample Identifier, configure the SlideMaker Slide labels without a bar-code. Questions regarding the Product Corrective Action should be directed to Beckman Coulter Customer Service at 1-800-526-7694 or your local Beckman Coulter Rep.
Worldwide Distribution -- USA and Canada.
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