IRON assay, Reference Numbers 6K95-41 and 6K95-30
- Company
- Sentinel Ch Spa Via Robert Koch
- Recall Initiated
- September 29, 2023
- Posted
- November 17, 2023
- Recall Number
- Z-0325-2024
- Quantity
- 4394 kits
Reason for Recall
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.
Distribution
Worldwide - US Nationwide distribution.
Lot / Code Info
Reference Number 6K95-41: UDI-DI: 00380740010928; Lot Number: 30610Y600; Reference Number 6K95-30: UDI-DI: 00380740010911; Lot Numbers: 21058Y600, 21101Y600, 30918Y600
Root Cause
Under Investigation by firm
Action Taken
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 examination and other biochemical tests as suggested by clinical guidelines. " Complete and return the Abbott Customer Reply Form. " Please retain this letter for your laboratory records. Transmission of this Field Safety Notice: This notice needs to be passed on to all those who need to be aware within your organization or to any organization/individuals where the potentially affected devices have been transferred. If you or any of your customers have any questions regarding this information, please contact your local area Abbott Customer Service.