Siemens N Latex IgM Reagent Recalled for Proficiency Testing Failures
Siemens Healthcare Diagnostics is recalling specific lots of N Latex IgM reagents because they failed proficiency testing, resulting in low recovery rates for serum samples.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a performance failure in testing accuracy rather than a direct physical hazard.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 26 units of N Latex IgM in-vitro diagnostic reagents. The affected products are used for the quantitative determination of IgM in human cerebrospinal fluid and paired CSF/serum samples using the BN II and BN ProSpec Systems. The recall involves Catalog # OQAC11, lots 44018, 44019, and 44042, with an expiration date of 4/3/2015.
The recall was initiated after complaints confirmed that the reagent kits failed proficiency testing. Specifically, serum samples showed too low recovery rates when using the affected lots. This issue may affect the accuracy of immune system evaluations for patients.
The affected products were distributed worldwide, including in the United States (UT, CO, CA, FL, NY, OH, NC) and Canada. Healthcare facilities and laboratories should stop using the affected lots and contact Siemens Healthcare Diagnostics for instructions on return or replacement.
The recalled product
- Product
- N Latex IgM; In-vitro diagnostic reagent for the quantitative determination of IgM in human cerebrospinal fluid (CSF) and in paired CSF/serum samples by means of particle-enhanced immunonephelometry using the BN II and BN ProSpec Systems. The determination of IgM aids in the eval
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 26
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Catalog # OQAC11
- lots 44018
- 44019 and 44042
- expiration 4/3/2015
Distribution
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