Abbott Laboratories: "HEMOGLOBIN A1c CALIBRATORS *** REF 4P52-01 *** 307261/R03 *** S4P5X0 *** FOR USE WITH ARCHITECT" - Product Usage: use in the calibration of the Hemoglobin A1c assay.

Recall number

Z-1688-2020

Recalling firm

Abbott Laboratories

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.

Status

Terminated

Initiated

2019-05-22

Posted

not on file

Terminated

2021-01-22

Reason

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.

Root cause

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

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.

Lot, serial or model codes

List Number: 4P52-01 Lot Number: 54582UQ02

510(k) numbers

["K140654"]

PMA numbers

not on file

Product code

JIT

Firm FEI

3016438761

Firm city

Irving

Firm state

TX

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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