MalfunctionCJE

ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2

Received Jun 18, 2026 · Event occurred May 25, 2026

Report 1823260-2026-02434 · MDR key 25549547

Device

Generic name

Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes

Manufacturer

Roche Diagnostics

Catalog number

08056757190

Lot number

935593

Product problems

Incorrect, Inadequate or Imprecise Result or Readings

Patient

NA · Unknown

No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2 ASSAY RESULT FOR A PATIENT SAMPLE TESTED ON THE COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 123 U/L. THE REPEAT RESULTS WERE 62.1 U/L AND 58.4 U/L.

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE ANALYZER IS (B)(6) THE INVESTIGATION IS ONGOING.