Recall Z-0134-2021 ยท CJO Alpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes
Siemens Healthcare Diagnostics, Inc.
Siemens Dimension Vista Akaline Phosphatase (ALPI) Flex reagent cartridge - In vitro diagnostic test for the quantitative measurement of alkaline phosphatase in human serum and plasma Catalog Number: K2115, SMN# 10642444
| Date | Oct 20, 2020 (initiated Aug 25, 2020) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Under Investigation by firm |
| Action | Siemens issued Urgent Medical Device Recall (UMDC # VC-20-02.A.US via Fed'X) and Urgent Field Safety Notice (UFSN # VC-20-02.A.OUS) on August 25, 2020 to all Dimension Vista customers who received the Dimension Vista ALPI flex reagent lots 19247AB, 19282BB and 19330BD to notify them of the issue, health risk and actions to take. Customers were instructed to: Discontinue use of and discard the Dimension Vista ALPI lots 19247AB, 19282BB, 19330BD. Review their inventory of these lots to determine their laboratorys replacement needs. Complete and return the attached form to this letter to requ |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122323 | DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION VISTA ALKALINE PHOSPHATASE CALIBRATOR (ALPI Siemens Healthcare Diagnostics, Aug 28, 2012 |