Roche B-CrossLaps/serum Immunoassay Recalled for Unreliable Biotin Interference Claims
Roche Diagnostics is recalling B-CrossLaps/serum immunoassays because internal investigations showed the package insert's claims regarding biotin interference and sample stability could not be reproduced.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the source text explicitly states that false results may lead to delayed diagnosis and treatment of osteoporosis, which fits the rubric criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 3,056 units of B-CrossLaps/serum (B-CTx in serum) immunoassays, reference number 11972308. The product is an in vitro quantitative test used to determine degradation products of type I collagen in human serum and plasma, serving as an aid in assessing bone resorption and monitoring antiresorptive therapies in postmenopausal women and individuals with osteopenia.
The recall was initiated after internal research and development investigations revealed that the claims regarding biotin interference and sample stability provided in the Elecsys B-CrossLaps assay package insert (version 5) could not be reproduced. The source text notes that because the test results contribute to monitoring antiresorptive therapy, false low or false normal results may lead to delayed diagnosis and treatment of osteoporosis.
The affected units were distributed nationwide across the United States, including the states of AL, CA, GA, FL, IL, IN, KS, KY, MA, MD, MI, MN, MO, NC, NY, OH, PA, TX, VA, VT, and WA. The recall applies to all lot numbers of the specified product.
The recalled product
- Product
- B-CrossLaps/serum (B-CTx in serum) REF 11972308 160 100 tests Immunoassay for the in vitro quantitative determination of degradation products of type I collagen in human serum and plasma as an aid in assessing bone resorption. The test may be used as an aid in monitoring an
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Affected units
- 3,056
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 (1)
- All lot numbers
Distribution
Related recalls
Same manufacturer · Roche Diagnostics Operations, Inc.
See all →- HighRoche cobas analyzer may repeat previous results for spline calibrated assays
FDA (Devices) · 2026-03-11
- HighThyroid receptor immunoassay recalled over variable results across instrument platforms
FDA (Devices) · 2026-01-14
- HighMedical Device Homocysteine Test Assay Recalled for Calibration Defects
FDA (Devices) · 2024-11-27
- HighRoche Creatine Kinase test reagents recalled for calibration errors
FDA (Devices) · 2024-10-02
- HighRoche Tina-quant D-Dimer Test System Recalled for Inaccurate Results
FDA (Devices) · 2023-11-29
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02