MicroScan B1010-41ARecalls & reported problems
Beckman Coulter, Inc. · MicroScan Kovac's Reagent - 30ml · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15099590655204), received between May 1, 2026 and May 1, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Manufacturing, Packaging or Shipping Problem1
Patient problems
- Chemical Exposure1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 1, 2026Manufacturing, Packaging or Shipping Problem
THE CUSTOMER IN JAPAN REPORTED ONE BOTTLE OF B1010-41A MICROSCAN KOVAC¿S REAGENT LOT 2026-11-13 ARRIVED LEAKING. THE PACKAGE ARRIVED WITH THE OUTER PACKAGING CONTAMINATED WITH THE REAGENT. UPON INSPECTION OF THE BOTTLE, IT WAS NOTED THE CAP WAS INSUFFICIENTLY TIGHTENED AND SHRINK-WRAPPED TO THE BOTTLE IN A TILTED STATE. AT THE TIME OF DISCOVERY, THE ODOR OF THE LEAKED REAGENT WAS EXTREMELY STRONG, AND TWO STAFF MEMBERS FELT UNWELL REPORTING ONGOING COLD-LIKE SYMPTOMS, EYE AND RESPIRATORY IRRITATION. ONE OF THE TWO EXPOSED STAFF MEMBERS DID SEEK OUT MEDICAL ATTENTION AND WAS PRESCRIBED MEDICATION. BOTH STAFF MEMBERS HAVE FULLY RECOVERED.
Patient problems: Chemical Exposure
MAUDE report 25059416 ↗
Other Gram Negative Identification Panel devices
- VITEK® 2 GNBiomerieux , Inc. · Gram negative identification panel1 recall144 reports
- BD Phoenix™ NID 448007Becton, Dickinson And Company · GRAM NEGATIVE IDENTIFICATION PANEL138 reports
- BD BBL™ Crystal™ E/NF 245000Becton, Dickinson And Company · GRAM NEGATIVE IDENTIFICATION PANEL1 report
- MicroScan B1017-411Beckman Coulter, Inc. · Gram Negative Identification Panel1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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