Ortho VITROS Prolactin Reagent Pack Recalled for Biotin Interference
Ortho Clinical Diagnostics is recalling VITROS Prolactin Reagent Packs because biotin supplements may cause biased test results at lower concentrations than stated in the instructions.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a potential for biased results without reporting any specific injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Ortho Clinical Diagnostics Inc is recalling 1,790 units of VITROS Immunodiagnostic Products - Prolactin Reagent Pack (10758750000111) 1849793. The affected products were distributed nationwide in the US and in numerous countries worldwide, including Australia, Canada, China, and the United Kingdom.
The recall was initiated because the firm determined that biased results may occur for specific VITROS Immunodiagnostic Products (MicroWell Assays) at biotin concentrations lower than those indicated in the current Instructions For Use (IFU). Patients taking biotin supplements could potentially have biased sample results for the affected assays at these lower biotin concentrations.
No specific lot numbers or expiration dates are provided in the source text. Healthcare facilities and laboratories should contact Ortho Clinical Diagnostics for further instructions on handling the recalled reagent packs.
The recalled product
- Product
- VITROS Immunodiagnostic Products - Prolactin Reagent Pack (10758750000111) 1849793
- Manufacturer
- Ortho Clinical Diagnostics Inc
- Affected units
- 1,790
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)
- 2330 2340 2350 2360 2370 2380
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Ortho Clinical Diagnostics Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · Ortho Clinical Diagnostics Inc
See all →- ModerateLactate test slides recalled over calibration failures delaying patient results
FDA (Devices) · 2025-09-24
- ModerateLactate slides in 18-slide cartridges recalled over calibration failures delaying results
FDA (Devices) · 2025-09-24
- ModerateCalcium test slides recalled after calibration failures delayed patient results
FDA (Devices) · 2025-08-27
- HighVITROS CHE slides can cause quality control drift with performance verifiers
FDA (Devices) · 2025-07-23
- HighVITROS Performance Verifier II lots can cause quality control drift
FDA (Devices) · 2025-07-23
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- HighVITROS Prolactin Reagent Recalled for Low-End Measurement Imprecision
FDA (Devices) · 2022-05-25
- HighFDA Recalls VITROS Immunodiagnostic LH Reagent Pack for measurement imprecision
FDA (Devices) · 2022-05-25
- ModerateOrtho-Clinical Diagnostics Recalls VITROS Anti-HBe Reagent Packs
FDA (Devices) · 2019-01-09
- HighVITROS Intact PTH Reagent Pack recalled for negatively biased measurement results
FDA (Devices) · 2023-01-11
- HighVITROS Immunodiagnostic Hormone Reagents Recalled for Measurement Imprecision
FDA (Devices) · 2022-05-25
- ModerateOrtho-Clinical Diagnostics Recalls VITROS Intact PTH Reagent Packs
FDA (Devices) · 2017-01-04