Siemens Healthcare Diagnostics Products Ltd.
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.
Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085; L2KSY6/10488319 IVD, RxOnly
Lot Code: D387/UDI(s):L2KSY2-00630414999791; L2KSY6 - 00630414999807
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →