REF: 4P52-20 Hemoglobin A1c for use with Architect, IVD, CE, R1 1 x 52 mL, R2 1 x 20 mL, A1cDL 2 x 35 mL
Recall
- Recall Number
- Z-1454-2022
- Event Number
- 90499
- Firm
- Abbott Laboratories
- FEI Number
- 3016438761
- Product Code
- PDJ
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- June 9, 2022
- Address
- 1915 Hurd Dr, Irving, TX, 75038
Description
REF: 4P52-20 Hemoglobin A1c for use with Architect, IVD, CE, R1 1 x 52 mL, R2 1 x 20 mL, A1cDL 2 x 35 mL
There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using the ARCHITECT and Alinity c Hemoglobin A1c assay.
On June 9, 2022, Abbott issued a "Urgent Medical Device Correction" to affected consignees via FedEx. 1. Immediately install the updated assay file versions listed below (as applicable for your laboratory), and manually configure the Low-Linearity value. The assay files can be obtained from www.corelaboratory.abbott 2. For the whole blood application, manually configure the THbWB Low-Linearity to 53.8278. For the hemolysate application, manually configure the THbH Low-Linearity to 1250. For detailed information on editing assay parameters, refer to Changing assay configuration settings, Change a linearity range in the ARCHITECT System Operations Manual, Section 2. 3. Please review this letter with your Medical Director or Laboratory Management and follow your laboratory protocol regarding the need for reviewing previously reported patient results. 4. Complete and return the Customer Reply Form. 5. Please retain this letter for your laboratory records. 6. If you have forwarded the product listed above to other laboratories, please inform them of this Product Correction and provide to them a copy of this letter.
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