Recall Z-0326-2024 ยท JIY Photometric Method, Iron (Non-Heme)
Sentinel CH SpA
Alinity c Iron Reagent, Reference Number 08P3920
| Date | Nov 17, 2023 (initiated Sep 29, 2023) |
| Status | Open, Classified |
| Reason | A high recovery of Iron assay has been observed at some customer sites. Internal studies confirmed the positive shift of Quality Control and patient samples results, up to 15% for Iron Products (Alinity c Iron Reagent REF. 08P3920) to be used on Abbott Alinity Instrument and to 30% for Iron Products (IRON REF. 6K95-41 and IRON REF. 6K95- 30) to be used on Abbott Architect Instrument. When using the affected lots, there is a potential for delay in reporting patient results due to QC failure, also a potential for falsely elevated results. |
| Root cause | Under Investigation by firm |
| Action | A Field Safety Notice letter dated 9/29/23 was sent to customers. Actions to be taken: " Discontinue the use of and destroy any remaining inventory of the affected lots listed above of IRON for use with ARCHITECT REF 6K95-41, REF 6K95-30 and Alinity c Iron Reagent Kit REF 08P3920 according to your laboratory procedures. " Review this letter with your Medical Director or Laboratory Management and follow your laboratory protocol regarding the need for reviewing previously reported patient results. Results should always be assessed in conjunction with the patient's medical history, clinical exam |
| Quantity | 4400 kits |
| Distribution | Worldwide - US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.