inforMED
MalfunctionCEC

ALINITY I FREE T4 REAGENT KIT

Received Apr 20, 2026 · Event occurred Feb 2, 2026

Report 3005094123-2026-00188 · MDR key 24927943

Device

Generic name

Radioimmunoassay, Free Thyroxine

Catalog number

07P70-20

Product problems

  • Imprecise or Erratic Results

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION.

Description of Event or Problem

THE CUSTOMER OBSERVED IMPRECISION FOR THE ALINITY FREE T4 ASSAY. THE CUSTOMER HAS ALSO CONFIRMED THAT THEY ARE REPEATING ALL FT4S ABOVE OR BELOW THE REFERENCE RANGE WHERE THE TSH IS WITHIN THE REFERENCE RANGE. NORMAL RANGE OF 9.01 TO 19.05 PMOL/L. THE FOLLOWING DATA WAS PROVIDED: SID / DATE / TIME / RESULTS (B)(6) ON (B)(6) 2026, 2:49:44 PM, EXCEPTION, EXCEPTION 8.4 9.9 (B)(6) ON (B)(6) 2026, 2:30:38 PM, 8.2 8.2 9.3. (B)(6) ON (B)(6) 2026, 4:22:39 PM, 8.3 8.3 9.3. (B)(6) ON (B)(6) 2026, 10:50:56 AM, 8.3 8.3 9.3. (B)(6) ON (B)(6) 2026, 5:48:01 PM, 8.3 8.3 9.3. (B)(6) ON (B)(6) 2026, 1:50:24 PM, 8.4 8.4 9.3. (B)(6) ON (B)(6) 2026, 7:41:42 PM, 7.7 7.7 9.5. (B)(6) ON (B)(6) 2026, 3:09:59 AM 8.5 8.5 9.5. (B)6) ON (B)(6) 2026, 6:40:48 PM, 8.6 8.6 9.6. (B)(6) ON (B)(6) 2026, 3:54:37 PM, 8.6 8.6 9.8. (B)(6) ON (B)(6) 2026, 6:12:00 PM, 8.6 8.6 9.8. (B)(6) ON (B)(6) 2026, 7:20:45 PM, 8.7 8.7 9.8. (B)(6) ON (B)(6) 2026, 7:03:01 PM, 8.9 8.9 9.8. (B)(6) ON (B)(6) 2026, 2:58:48 PM, 8.9 8.9 9.8. (B)(6) ON (B)(6) 2026 4:49:41 PM, 8.8 8.8 9.9. (B)(6) ON (B)(6) 2026, 12:59:49 PM, 9 9 9.9. (B)(6) ON (B)(6) 2026, 5:40:33 PM, 8.4 8.4 10. (B)(6) ON (B)(6) 2026, 2:24:49 PM, 8.7 8.7 10. (B)(6) ON(B)(6) 2026, 6:37:15 PM, 8.8 8.8 10. (B)(6) ON (B)(6) 2026, 7:48:12 PM, 8 8 10.1. (B)(6) ON (B)(6) 026, 3:37:59 PM, 8.6 8.6 10.1. (B)(6) ON (B)(6) 2026, 5:53:24 PM, 8.7 8.7 10.2. (B)(6) ON (B)(6) 2026, 5:50:42 PM, 8.8 8.8 10.2. (B)(6) ON (B)(6) 2026, 2:29:41 PM, 19.4 19.4 15.3. (B)(6) ON (B)(6) 2026, 4:11:01 PM, 22.5 22.5 16.2. (B)(6) ON (B)(6) 2026, 4:41:38 PM, 20.6 20.6 17.8. (B)(6) ON (B)(6) 2026, 4:44:36 AM, 20 20 18.6. (B)(6) ON (B)(6) 2026, 12:04:44 PM, 20.7 20.7 18.6. (B)(6) ON 2026, 5:03:34 PM, 21 21 19. (B)(6) 02/09/2026, 7:44:54 PM, 20.3 20.3 21.3 18.7 NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.