ARCHITECT 2P56-42Recalls & reported problems
Abbott GmbH · Lactate Dehydrogenase · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380740161477), received between Feb 7, 2020 and Jun 11, 2020 — classified as 3 malfunctions.
The most frequently reported specific device problem is “High Test Results” (3 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- High Test Results3
Patient problems
- No Consequences Or Impact To Patient2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 11, 2020High Test Results; High Test Results
THE CUSTOMER STATED THAT A FALSELY ELEVATED ARCHITECT LDH RESULT OF 337 U/L WAS GENERATED FOR A PATIENT SAMPLE THAT RETESTED AT 151 U/L ON THE SAME ARCHITECT ANALYZER AND 132/136 U/L ON A DIFFERENT ARCHITECT ANALYZER. THE CUSTOMER'S NORMAL RANGE IS 125 TO 220 U/L. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10146006 ↗MalfunctionFeb 25, 2020High Test Results; High Test Results
THE CUSTOMER STATED THAT A FALSELY ELEVATED ARCHITECT LDH RESULT OF 337 U/L WAS GENERATED FOR A PATIENT SAMPLE THAT RETESTED AT 151 U/L ON THE SAME ARCHITECT ANALYZER AND 132/136 U/L ON A DIFFERENT ARCHITECT ANALYZER. THE CUSTOMER'S NORMAL RANGE IS 125 TO 220 U/L. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9752912 ↗MalfunctionFeb 7, 2020High Test Results; High Test Results
THE CUSTOMER REPORTED A FALSE ELEVATED LACTATE DEHYDROGENASE (LDH) RESULT WHEN PROCESSING ON THE ARCHITECT C16000. THE INITIAL RESULT WAS 514 U/L AND RETEST WAS 198 U/L. RETESTING ON ANOTHER INSTRUMENT YIELDED RESULTS OF 195, 7, AND 197 U/L. THE CUSTOMER USES A REFERENCE RANGE OF 125-220 U/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9682538 ↗
Other NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE devices
- ARCHITECT 2P56-21Abbott Laboratories · NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE51 reports
- LDH P-L LD3818Randox Laboratories Limited · Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase1 recall0 reports
- LDH L-P LD3842Randox Laboratories Limited · Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase1 recall0 reports
- Lactate Dehydrogenase acc. to IFCC ver.2 08057958190Roche Diagnostics GmbH · NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE15 reports
- ARCHITECT 2P56-22Abbott GmbH · NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE13 reports
- Lactate Dehydrogenase acc to IFCC ver2 3004732122Roche Diagnostics GmbH · NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE8 reports
- Alinity 07P7420Abbott GmbH · NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE6 reports
- Lactate Dehydrogenase acc. to IFCC ver.2 5401674190Roche Diagnostics GmbH · NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.