Recall Z-0082-2017
Siemens Healthcare Diagnostics, Inc. · initiated August 24, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
SIEMENS IMMULITE/IMMULITE 2000 Systems Rubella IgM (RUM), REF/Catalog Number for US: L2KRM2(D), Siemens Material Number (SMN) for US: 10374021, REF/Catalog # for OUS: L2KRM2, SMN for OUS: 10381327; Unique Device Identification Number (UDI) 00630414961996; IVD --- For in vitro diagnostic use with the IMMULITE/IMMULITE 1000/IMMULITE 2000/IMMULITE 2000 XPi Systems Analyzers-for the qualitative detection of IgM antibodies to Rubella virus in human serum or plasma (EDTA and heparinized), as an aid in the presumptive diagnosis of an acute or recent rubella infection, particularly in women of childbearing age
Codes / lots: Kit lots 236M, 237, 238, 239, 239L (OUS) and D236M and D238 (US)
Reason for recall
Siemens received multiple customer complaints indicating an increase in false positive and indeterminate patient sample results and increased imprecision for several lots of Rubella IgM assay on the IMMMULITE 2000/IMMULITE 2000 XPi platforms.
FDA-determined cause: Under Investigation by firm
Action taken
Siemens sent an Urgent Medical Device Recall Letter IMC16-20.A.US , dated August 24, 2016, to the US consignees via FedEx, and an Urgent Field Safety Notice IMC16-20.A.OUS (dated August 2016) was sent to foreign representatives for distribution to foreign consignees. Customers were instructed to discontinue use of and discard the affected kit lots. Customers were also requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Recall letter within 30 days. Field service personnel will be sent an SKB (Service Knowledge Base) describing the issue and instructing them how to deal with customer questions. For questions, customers were instructed to contact their Siemens Customer Care Center or their local Siemens technical support representative.
Details
- Recall number
- Z-0082-2017
- Initiated
- August 24, 2016
- Terminated
- May 24, 2018
- Product code
- LFX – Enzyme Linked Immunoabsorbent Assay, Rubella
- Quantity
- Domestic: 177 Kits; Foreign: 3435 Kits
- Distribution
- Worldwide Distribution n- US (Nationwide) and Foreign distribution to the following countries: Argentina, Bangladesh, Brazil, Bulgaria, China, Colombia, Costa Rica, Cyprus, Egypt, France, Germany, Greece, Guatemala, India, Indonesia, Israel, Italy, Kazakhstan, Macedonia, Mexico, Paraguay, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Syria, United Arab…
- Recalling firm
- Siemens Healthcare Diagnostics, Inc., Tarrytown, NY
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0081-2017 Class II | SIEMENS IMMULITE/IMMULITE 1000 Systems Rubella IgM (RUM), REF/Catalog Number LKRM1…Siemens received multiple customer complaints indicating an increase in false positive and indeterminate… | 08/24/2016Terminated |