Z-1688-2020Class II

"HEMOGLOBIN A1c CALIBRATORS * REF 4P52-01 * 307261/R03 * S4P5X0 * FOR USE WITH ARCHITECT" -

Name: Z-1688-2020 "HEMOGLOBIN A1c CALIBRATORS *** REF 4P52-01 *** 307261/R03 *** S4P5X0 *** FOR USE WITH ARCHITECT" -
Creator: Abbott Laboratories
Published: 2019-05-22
License: https://open.fda.gov/license/

Abbott Medical / initiated 2019-05-22 / Terminated / root cause: manufacturing process

FDA source

Abbott Laboratories began a recall of "HEMOGLOBIN A1c CALIBRATORS *** REF 4P52-01 *** 307261/R03 *** S4P5X0 *** FOR USE WITH ARCHITECT" - Product Usage: use in the calibration of the Hemoglobin A1c... on 2019-05-22. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1688-2020
Classification: Class II
Status: Terminated
Initiated: 2019-05-22
Posted: 2020-04-09
Terminated: 2021-01-22
Recalling firm: Abbott Medical
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.
Product code: JIT Calibrator, Secondary
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.
Root cause tag: manufacturing process
FDA 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 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.
Product codes and lots: List Number: 4P52-01 Lot Number: 54582UQ02

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1688-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1688-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-15	2020-04-09

Product code JIT

K140654Class IIHemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c ControlsAbbott Laboratories / cleared 2015-05-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)