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.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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…
- 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
Related recalls
Same manufacturer · Siemens Healthcare Diagnostics, Inc.
See all →- HighSiemens Atellica CH C-Reactive Protein Reagent Recalled for Falsely Elevated Results
FDA (Devices) · 2026-10-07
- SevereSiemens Recalls Emit 2000 Quinidine Assay Due to Precision Issues
FDA (Devices) · 2026-08-26
- SevereSiemens Quinidine Assay Recalled for Precision Errors
FDA (Devices) · 2026-08-26
- HighSiemens Atellica CH Urine Albumin In Vitro Diagnostic Recall
FDA (Devices) · 2026-08-12
- LowSyva Emit Disopyramide Enzyme Immunoassay Calibrator Recalled for Sodium Azide Concentration
FDA (Devices) · 2026-08-12
Same hazard · inaccurate testing
See all →- ModerateAbbott Recalls Alinity c Cuvette Segments Due to Seating Defect
FDA (Devices) · 2019-06-12
- LowOrtho-Clinical Diagnostics Recalls VITROS Chemistry Products Cl- Slides
FDA (Devices) · 2018-09-19
- SeverebioMerieux VITEK 2 Gram Positive Test Kits Recalled for MRSA Detection Issues
FDA (Devices) · 2018-08-29
- HighTosoh HLC-723G8 Analyzer Recalled for HbA1c Test Inaccuracy
FDA (Devices) · 2017-03-01
- ModerateRoche Cobas c502 Analyzer Recall Due to Inactive Volume Check
FDA (Devices) · 2014-04-16
Similar recalls
- HighSiemens N Antiserum to Human IgG Recall for High-Dose Performance Failure
FDA (Devices) · 2022-10-26
- HighN Antiserum to Human IgG Fails High-Dose Hook Effect Performance Standards
FDA (Devices) · 2022-10-26
- HighSiemens N Cuvette Segments Recalled for Falsely Elevated Albumin Results
FDA (Devices) · 2019-08-28
- ModerateSiemens N Latex HCY Reagent Recalled for Stability Issues
FDA (Devices) · 2017-03-01
- ModerateSiemens IMMULITE 1000 Cortisol Assay Recalled for Positive Bias
FDA (Devices) · 2014-10-29
- HighSiemens Atellica CH Immunoglobulin M Reagent Quality Control Bias
FDA (Devices) · 2024-02-14