Beckman Coulter MicroScan PROMPT Inoculation System-D Recalled for Incorrect Wands
Beckman Coulter is recalling 3,472 units of the MicroScan PROMPT Inoculation System-D because they contain incorrect prompt wands, which may cause inaccurate antimicrobial susceptibility test results.
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 involves a medical device where the defect could lead to incorrect clinical test results (false-susceptible or false-resistant), which poses a risk of harm through misdiagnosis or inappropriate treatment, but no specific injuries or illnesses have been reported.
Plain-English summary
Beckman Coulter Inc. is recalling 3,472 units of the MicroScan PROMPT Inoculation System-D, Catalog Number B1026-10D, UDI: 15099590659561. The affected units are from Lot number 20201103T with an expiration date of 11/3/2020. The product is used to standardize inocula for microdilution antimicrobial susceptibility tests.
The recall was initiated due to customer reports that the inoculation system contains incorrect prompt wands. The use of these incorrect wands could result in false-susceptible results, false-resistant results, possible misidentifications, or possible out-of-range Quality Control results.
The affected products were distributed worldwide, including nationwide in the United States and in Canada, China, Japan, and Paraguay. Users should stop using the affected units and contact Beckman Coulter for further instructions.
The recalled product
- Product
- Beckman Coulter MicroScan PROMPT Inoculation System-D, Catalog Number B1026-10D, UDI: 15099590659561 - Product Usage: The Prompt Inoculation System-D is used to standardize inocula for microdilution antimicrobial susceptibility test.
- Manufacturer
- Beckman Coulter Inc.
- Affected units
- 3,472
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 (2)
- Lot number 20201103T
- Expiration Date: 11/3/2020
Distribution
Related recalls
Same manufacturer · Beckman Coulter Inc.
See all →- HighBeckman Coulter DxC 500 AU Analyzer Software Defect Recall
FDA (Devices) · 2026-08-26
- HighBeckman Coulter DxC 500i Analyzer Modules Recalled for Software Defect
FDA (Devices) · 2026-08-26
- High
- SevereBeckman Coulter MicroScan Panel Update DVD Kits Recalled
FDA (Devices) · 2026-08-12
- HighBeckman Coulter Access Total T4 Calibrator Recalled for Inaccurate Results
FDA (Devices) · 2026-04-29
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