Merck Minicon Clinical Sample Concentrators Recalled for Performance Issues
Merck Millipore is recalling Minicon Clinical Sample Concentrators because they may take up to 24 hours to concentrate samples, delaying diagnostic tests.
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 hazard is a performance delay (increased concentration time) rather than a direct safety risk like contamination or injury, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Merck Millipore Ltd. is recalling 1,360 units of Minicon Clinical Sample Concentrators for In Vitro Diagnostic Use, specifically models 9031 (Minicon B-15) and 9051 (Minicon CS-15). These non-sterile, disposable devices are intended for concentrating serum, urine, cerebrospinal fluid, and other body fluids prior to analysis.
The recall is due to a performance issue where the devices, when used more than six months after the date of manufacture, may have increased concentration times. While the specification is 3 hours, the concentration time may extend up to 24 hours. This delay may lead to postponements in carrying out subsequent analysis tests.
The affected units were distributed nationwide in the United States to specific states, as well as to Canada and Australia. Users should stop using the affected lots and contact Merck Millipore for instructions on return or replacement.
The recalled product
- Product
- Minicon Clinical Sample Concentrators for In Vitro Diagnostic Use 9031 (Model: Minicon B-15) & 9051 (Model: Minicon CS-15) Minicon concentrators are non-sterile, disposable, multiwall ultrafiltration devices. Minicon¿ clinical sample concentrators are for in vitro diagnostic…
- Manufacturer
- Merck Millipore Ltd.
- Affected units
- 1,360
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 (20)
- R7HA25141
- R7HA25142
- R7HA25143
- R7JA25144
- R7JA29966
- R7KA29967
- R7KA37204
- R7KA47996
- R7KA47998
- R7MA62669
- R7MA62670
- R7MA62671
- R7MA70413
- R7MA73041
- R7NA73042
- R7NA76185
- R7NA76186
- R7NA84720
- R7PA90587
- R7PA90588
Distribution
Related recalls
Same hazard · performance defect
See all →- SevereBD Alaris Pump Infusion Sets Recalled for Performance Data Discrepancies
FDA (Devices) · 2026-09-23
- ModerateBD GasPak EZ Campy Pouch System Recall for Below-Specification Gas Production
FDA (Devices) · 2026-05-06
- ModerateBD GasPak EZ CO2 Pouch System gas generating sachets underperforming
FDA (Devices) · 2026-05-06
- ModeratePhilips C5-2 Ultrasound Transducers Refurbished Beyond Useful Life
FDA (Devices) · 2025-07-09
- ModerateThermo SCIENTIFIC Sensititre Mueller-Hinton Broth diagnostic device recalled
FDA (Devices) · 2025-06-18
Similar recalls
- HighSiemens BCS Behring Coagulation System Recalled for Potential Test Errors
FDA (Devices) · 2012-07-04
- HighMedtronic Hemocor Hemoconcentrators Recalled for Low Ultrafiltration Performance
FDA (Devices) · 2015-09-16
- HighICU Medical Recalls NanoClave Sets Due to Potential Seal Defect
FDA (Devices) · 2020-10-28
- HighAmeditech MicroScreen Immunoassay Recalled for Inconsistent Detection Performance
FDA (Devices) · 2020-10-07
- SevereMedtronic Recalls INDURA 1P Intrathecal Catheters Due to Occlusion Risk
FDA (Devices) · 2013-07-03
- ModerateICU Medical Recalls Intravascular Administration Sets Due to Manufacturing Defect
FDA (Devices) · 2020-10-28