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U.S. Department of Health and Human Services

Class 2 Device Recall ARCHITECT Hemoglobin A1c Calibrators

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  Class 2 Device Recall ARCHITECT Hemoglobin A1c Calibrators see related information
Date Initiated by Firm May 22, 2019
Create Date April 09, 2020
Recall Status1 Terminated 3 on January 22, 2021
Recall Number Z-1688-2020
Recall Event ID 85247
510(K)Number K140654  
Product Classification Calibrator, secondary - Product Code JIT
Product "HEMOGLOBIN A1c CALIBRATORS *** REF 4P52-01 *** 307261/R03 *** S4P5X0 *** FOR USE WITH ARCHITECT" - Product Usage: use in the calibration of the Hemoglobin A1c assay.
Code Information List Number: 4P52-01 Lot Number: 54582UQ02
Recalling Firm/
Manufacturer		 Abbott Laboratories
1915 Hurd Dr
Irving TX 75038
For Additional Information Contact Albert Chianello
877-422-2688
Manufacturer Reason
for Recall		 Calibrator level 2 bottle may have been manufactured incorrectly for a portion of the lot. The manufacturer observed no impact to assay performance between the HbA1c concentration range of 5.33% to 6.87%. However, outside of this range, a bias of greater than 3% may be seen with patient results. The device failure that is associated with this recall can result in potentially negatively and positively biased patient test results for HbA1c. The firm is investigating the root cause.
FDA Determined
Cause 2		 Under Investigation by firm
Action On May 22, 2019 the firm issued the Product Recall letter along with a customer reply form to all customers informing them that the firm has identified that the calibrator level 2 may have been manufactured incorrectly for a portion of the lots and that although this lot may generate an active calibration curve, a shift to QC and patient results may occur. Between concentration range of 5.33% to 6.87% there is no impact to assay performance, however, outside of this range, a bias of greater than 3% may be seen with patient results. For US customers the Product Recall Letters were sent via FedEx Priority Overnight Express (note-for OUS, each country organization will establish their own method of notification, which consistence of mailings or customer visits). The Product Recall Letter instructed customers to: - Immediately discontinue use of the calibrator lot number and switch to the alternate calibrator lot. - Destroy any remaining inventory of impacted material according to customer's laboratory procedures. - Review this letter with Medical Director or Laboratory Management and follow laboratory protocol regarding the need for reviewing previously reported patient results. - Complete and return the Customer Reply Form. Contact your local firm representative for assistance with replacement product. - If customers have forwarded the product to other laboratories, please inform them of this Product Recall and provide them with a copy of this letter. - Please retain this letter for your laboratory records. If any health care providers have any questions regarding this information, U.S. Customers please contact Customer Service at 1-877-4ABBOTT (available 24 hours a day, 7 days a week). Customers outside the U.S., please contact your local area Customer Service. If any patient or user injury are experienced associated with this Field Action, please immediately report the event to your local area Customer Service.
Quantity in Commerce 198 Kits
Distribution Worldwide distribution - US Nationwide distribution in the states of AR, AZ, CA, FKL GA, IA, ID, IL, IN, KS, LA, MN, MO, NC, NE, NJ, NV, NY, OH, OK, PA, SC, SD, TX, UT, VA, and WI; and countries of Austria, Germany, Italy, South Africa, and Spain.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JIT and Original Applicant = ABBOTT LABORATORIES
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