Reported May 6, 2020 · Terminated
Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software version v1.21.0 SP1 or lower
Siemens Healthcare Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics, Inc. · 511 Benedict Ave · Tarrytown, NY · 10591-5005
Is this the product you have?
- Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software version v1.21.0 SP1 or lower
- Lot codes and dates
- UDI
00630414002163All systems with software version v1.21.0
- SP1 or lower Serial Numbers
1,399 of 1,399 codes
CM01702CM01708CM00184CM00196CM01051CM01467CM00770CM00815CM00983CM01053CM00802CM01004CM01903CM00526CM00635CM00809CM00733CM00735CM01045CM01050CM01052CM01059CM00420CM00632CM00633CM00209CM00210CM01799CM01590CM01612CM01047CM01048CM00859CM00865CM01624CM01626CM00829CM00830CM00651CM00654CM01603CM01608CM01695CM01701CM00749CM00786CM01567CM01569CM01682CM01683CM00773CM01431CM01474CM01583CM01598CM01602CM00148CM00151CM00152CM01907
- UDI
- Amount recalled
- 1807
Where it was sold
- Nationwide
Why it was recalled
Editing an assay Test Definition and switching to another assay s Test Definition screen without saving the changes using the save button on the screen, may corrupt the settings of the assay s test definition, and Auto-Rerun or Auto-Dilution results may generate a result of Zero (0) for quantitative assays or Negative for qualitative assays if a well of the reagent pack is not calibrated.
This product could cause temporary or reversible health problems — stop using it.
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