ABL90 FLEX SP90 944-157Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05700699441577), received between Dec 22, 2016 and Feb 3, 2023 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2023Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE COMPLAINT, ON (B)(6) 2022, WHEN THE USER WAS USING THE ABL90 FLEX ANALYZER, IT WAS DISCOVERED THAT THE ABL90 FLEX SOLUTION PACK (LOT NUMBER: NA18) WAS FOUND TO BE LEAKING. NO HARM TO THE USER OR PATIENT WAS REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16289634 ↗
• MalfunctionOct 30, 2020Leak/Splash; Leak/Splash

  ACCORDING TO THE COMPLAINT THE USER FOUND A LOT OF LIQUID LEAKAGE FROM THE SOLUTION PACK(SP) SEVERAL DAYS AFTER THE 90SP WAS INSTALLED. NOBODY TOUCHED THE LEAKED LIQUID DIRECTLY. THE SP CONTAINED CONTAMINATED BLOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10761727 ↗
• MalfunctionFeb 2, 2018Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE COMPLAINT, ON (B)(4) 2017, A CUSTOMER GOT THE ERROR MESSAGES BELOW ON ABL90 DISPLAY, AND THEY COULD NOT MEASURE A SAMPLE. ANALYZER NEED MAINTENANCE. LEAK CURRENT DETECTED (#(B)(4)). THE CUSTOMER REMOVED THE SOLUTION PACK FROM ABL90 AND RE-INSTALLED IT BECAUSE THE SOLUTION PACK WAS FRESH. THEY INSTALLED A NEW 90SP WITHIN A DAY. THEN THEY FOUND PINK LIQUID LEAKAGE FROM THE BOTTOM OF THE SOLUTION PACK. IT WAS REPORTED THAT THE SOLUTION PACK HAD A SLIGHT LEAK AT THE CUSTOMER SITE, BUT IT WAS LEAKING A LOT AT RADIOMETER (B)(4) SITE. THE CUSTOMER DID NOT GET IN CONTACT WITH THE LEAKED LIQUID, BUT AN RADIOMETER (B)(4) EMPLOYEE GOT IN CONTACT WITH A BIT OF LEAKING LIQUID WHEN RECEIVING THE SOLUTION PACK.

  Patient problems: No Patient Involvement

  MAUDE report 7236658 ↗
• MalfunctionOct 11, 2017Mechanical Problem; Mechanical Problem

  THE CUSTOMER EXPERIENCED LIQUID LEAKAGE FROM ABL90 SOLUTION PACK DURING ABL90 WORKING. A MEDICAL WORKER GOT IN TOUCH WITH THE LEAKED LIQUID, WHICH MAY CONTAIN BLOOD. HE GOT LIQUID ON HIS HAND, HIS SUITS, HIS SOCKS AND HIS BAG.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6939631 ↗
• MalfunctionJul 20, 2017Mechanical Problem; Mechanical Problem

  A MEDICAL WORKER TOUCHED THE LEAKED LIQUID THAT MAY CONTAIN BLOOD. SHE WORE GLOVES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6727373 ↗
• MalfunctionFeb 14, 2017Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE CUSTOMER THE SOLUTION PACK HAD LEAKED ALL OVER THE ANALYZER AND BENCH AND THE ANALYZER WAS REQUESTING A REPLACEMENT. THE SOLUTION PACK WAS TAKEN TO THE RADIOMETER OFFICE AND OPENED. IT COULD BE SEEN THAT THE WASTE POUCH HAD LEAKED OUT AND WAS EMPTY. MOST OF THE LIQUID WAS CONTAINED WITHIN THE OUTER CASE OF THE SOLUTION PACK BUT THERE WAS SOME ON THE OUTSIDE AS WELL. THE ANALYSER IS USED FOR ANIMAL BLOOD. THE OPERATOR WORE GLOVE AND THE INCIDENT DID NOT CAUSE HARM TO ANYONE.

  Patient problems: No Patient Involvement

  MAUDE report 6328681 ↗
• MalfunctionDec 22, 2016Fluid/Blood Leak; Fluid/Blood Leak

  THE SOLUTION PACK GAVE A LEAKING PACK ERROR. WHEN THE USER REMOVED THE SOLUTION PACK FROM THE ANALYZER THERE WAS A POOL OF PINK LIQUID ON THE BOTTOM OF THE ANALYZER. WHEN THE USER LIFTED THE SOLUTION PACK, PINK LIQUID POURED OUT EVERYWHERE ON THE FLOOR. INSPECTION OF THE SOLUTION PACK SHOWED THAT THE PINK SOLUTION CAME FROM THE WASTE POUCH WHICH CONTAINS WASTE LIQUID INCLUDING BLOOD. NOBODY CAME INTO CONTACT WITH THE SOLUTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6197961 ↗