Siemens Dimension Vista Akaline Phosphatase recall
Siemens Dimension Vista Akaline Phosphatase (ALPI) Flex reagent cartridge - In vitro diagnostic test for the quantitative measurement of alkaline…
Why was Siemens Dimension Vista Akaline Phosphatase recalled?
Low outlier resultsgenerated with Alkaline Phosphatase (ALPI) Flex reagent cartridge.The maximum difference observed with a patient sample was approximately -27% at a concentration of 129 U/L (2.15 ukat/L). The low outlier results are generated from the last five (5) tests of the well
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Number/UDI/Exp. Date: 1) 19247AB UDI: 0084276803903419247AB20090310642444840 Exp.2020-09-03, (2) 19282BB UDI: 0084276803903419282BB20100810642444840 Exp. 2020-10-08, (3) 19330BD UDI:0084276803903419330BD20112510642444840 Exp. 2020-11-25. Expanded Recall: 3/10/21 20337AB, 20311BA, 20275AA, 20218AA, 20203BA, 20170AA, 20125BA, 20078AB.
- Product
- Siemens Dimension Vista Akaline Phosphatase (ALPI) Flex reagent cartridge - In vitro diagnostic test for the quantitative measurement of alkaline…
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- US:5970 units ; OUS: 1446 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Australia, Austria, Belgium, Bahamas, Czech Republic, Denmark, France, Germany, Italy, Japan, Korea, Netherlands, Norway, New Zealand, Portugal, Slovakia, Slovenia, Spain, Switzerland.
- Recall date
- October 28, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)