STA® - Cleaner Solution 00973Recalls & reported problems
Diagnostica Stago · Class 1
- 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 03607450009736), received between Aug 29, 2018 and Aug 29, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Device Damaged Prior to Receipt by User” (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.
Most reported problems
Device problems
- Device Damaged Prior to Receipt by User1
- Manufacturing, Packaging or Shipping Problem1
Patient problems
- Burn(s)1
- Skin Discoloration1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 29, 2018Device Damaged Prior to Receipt by User; Manufacturing, Packaging or Shipping Problem; Device Damaged Prior to Receipt by User; Manufacturing, Packaging or Shipping Problem
ON (B)(6) 2018: STAGO RECEIVED A COMMUNICATION FROM (B)(6), THE CLINICAL LABORATORY EDUCATOR/SAFETY COORDINATOR AT (B)(6). SHE CLAIMS THAT THEY "RECEIVED SOME STA CLEANER SOLUTION FOR THE EVOLUTION/COMPACT THAT LEAKED BECAUSE THE BOX WAS CRUSHED DURING TRANSPORT" AND WHEN HER INVENTORY SPECIALIST WAS DUMPING IT DOWN THE SINK IT SPLASHED ON HIM. IT "BURNED HIS SKIN AND DISCOLORED IT". (B)(6) ALSO STATED THAT THE SHIPPING COMPANY TOOK THE REAGENT OUT OF THE ORIGINAL BOX, PLACED IT INTO AN UNMARKED BOX AND WRAPPED IT WITH PACKING TAPE. ACCORDING TO THE PERSON INVOLVED, "ONE OF THE PACKAGES WAS JUST A ROUND BALL OF PACKING TAPE WITH THE (B)(6) LABEL TAPED ON. IT WAS NOT A BOX WHEN OPENING. EVERYTHING WAS WET. THE BOTTLES WERE PUNCTURED AND CRUSHED." AT FIRST, HE DID NOT KNOW IT WAS LEAKING SINCE THERE WAS NOT ANY PAPERWORK WITH THE ITEM, BUT REALIZED WHAT IT WAS WHEN HE SAW THE BOTTLES. TWO OF THE 4 BOXES SHIPPED WERE DAMAGED. ON 16AUG2018: (B)(6) WAS CONTACTED BY STAGO TO OBTAIN MORE INFORMATION ABOUT THE INCIDENT. ACCORDING TO HER THE PERSON INVOLVED HAS A SEVERE ALLERGY TO BLEACH. IT SHOULD BE NOTED THAT STA CLEANER SOLUTION IS A HIGHLY DILUTE DISINFECTANT WHICH DOES NOT CONTAIN BLE
Patient problems: Burn(s); Skin Discoloration
MAUDE report 7827161 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.