ABBOTT PRISM 6A36-34Recalls & reported problems
Abbott Laboratories · ABBOTT PRISM NEXT MAIN INSTRUMENT SIX CHANNEL · Class N
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380740008574), received between Apr 24, 2017 and Nov 1, 2017 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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
- Adverse Event Without Identified Device or Use Problem1
- Device Operates Differently Than Expected1
Patient problems
- Injury1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 1, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
WHILE SERVICING THE PRISM ANALYZER THE ABBOTT AMBASSADOR INJURED HIMSELF WHILE LIFTING THE SAMPLE PLATE ASSEMBLY. HE HAD AN ULTRASOUND PERFORMED AND WILL BE UNDERGOING SURGERY ON (B)(6) 2017 DUE TO AN AGGRAVATED HERNIA. IN ADDITION HE CANNOT LIFT ANYTHING OVER 20 LBS.
Patient problems: Injury
MAUDE report 6995130 ↗MalfunctionApr 24, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected
THE CUSTOMER REPORTS THAT THE ABBOTT PRISM NEXT ANALYZER MISREAD SAMPLE BARCODE LABEL (B)(6) AS 831646. NO ERROR MESSAGES WERE GENERATED AND THE LABEL DOES NOT APPEAR TO BE DAMAGED. THE CUSTOMER RE-READ THE BARCODE ON THE ANALYZER THE NEXT DAY AND THE CORRECT IDENTIFICATION NUMBER WAS READ. THERE IS NO IMPACT TO PATIENT/DONOR MANAGEMENT REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6516615 ↗
Other TEST,EQUIPMENT,AUTOMATED BLOODBORNE PATHOGEN devices
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- ABBOTT PRISM 6A36-11Abbott Laboratories · TEST,EQUIPMENT,AUTOMATED BLOODBORNE PATHOGEN4 reports
- ORTHO 5561701Ortho-Clinical Diagnostics, Inc. · TEST,EQUIPMENT,AUTOMATED BLOODBORNE PATHOGEN1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.